18-BI-1206-03: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody CD32b (FcƴRIIB) in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: BioInvent International AB
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if a medicine not yet approved by the FDA, named BI-1206, will help in the treatment of advanced solid tumors and also how safe it is for people to use in combination with pembrolizumab, which is an approved drug under the trade name of Keytruda.
There are 2 parts to this study: Part 1 (dose escalation) Part 2 (dose expansion). When enrollment is completed to Part 1 then Part 2 (dose expansion) will open.
Inclusion Criteria:
– At least 18 years of age on day of signing informed consent.
– Has a histologically confirmed advanced solid tumor.
– Must have received at least 2 doses of an approved anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
– Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
– Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206 (on non-previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor-directed therapy.
– Has an ECOG performance status of 0-1.
– Has adequate organ function as confirmed by laboratory values.
– Has a life expectancy of at least 12 weeks.
Exclusion Criteria:
– Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
– Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated CNS metastases may participate provided they are radiologically stable.
– Has cardiac or renal amyloid light-chain amyloidosis.
– Has received chemotherapy or small molecule products within 4 weeks of first dose of BI-1206.
– Has received radiotherapy within 2 weeks of first dose of BI-1206.
– Has received immunotherapy within 4 weeks prior to the first dose of BI-1206.
– Has an active, known or suspected autoimmune disease.
– Has had an allogenic tissue/solid organ transplant.
– Has uncontrolled or significant cardiovascular disease.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients with Relapsed/Refractory Solid Tumors (PSB205-201)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Qilu Puget Sound Biotherapeutics Corporation
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This is a study of a drug called PSB205 for the treatment of solid tumors. PSB205 works in two ways and can cause fewer potential side effects than those caused by the combination of Nivolumab and Ipilimumab. PSB205 has been shown to have the same effect on tumors as the combination of Nivolumab and Ipilimumab.
Inclusion Criteria:
-Patients aged 18 years or older.
-ECOG Performance status of less than or equal to 2.
-Life expectancy of greater than or equal to 3 months.
-Adequate bone marrow, organ function and laboratory parameters.
-Female subjects who are not pregnant or breastfeeding.
-Recovered from all reversible AEs due to previous anticancer therapies.
-Suitable venous access for the study required blood sampling.
-Must have one of the following solid tumors: Advanced or metastatic clear cell RCC or non-clear cell RCC, urothelial cancer, small cell lung cancer, advanced soft tissue or bone sarcoma, metastatic melanoma, or mismatch-repair-deficient malignancies.
Exclusion Criteria:
-Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years.
-Untreated central nervous system metastatic disease, leptomeningeal disease, or cord compression.
-Hypertension unable to be controlled with medication.
-Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
-Prior treatment with a CTLA-4 inhibitor in combination with a PD-1 or PD-L1 inhibitor.
-Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery.
-Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
-Subjects with a history of organ transplant.
-Hepatitis B surface antigen-positive or known or suspected active hepatitis C infection.
-Known human immunodeficiency virus (HIV) positive.
Study Contact:
Lisa Wahowske, RN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Turning Point Therapeutics
Location: Regions Cancer Care Center
Phase of Study: Phase 2
Purpose of study: This is an investigational study of a drug named Reprotrectinib that will be given to patients with advanced solid tumors with ALK, ROS1, or NTRK1-3 rearrangements. Repotrectinib will provide opportunities in clinic to stop the abnormal cell signaling of ALK/ROS1/TRKs in solid malignancies, and overcome your body’s natural resistance to treatment of advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements.
Inclusion Criteria:
-18 years of age or older
-Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
-At least 1 measurable lesion according to RECIST (v1.1)
-Prior cytotoxic chemotherapy is allowed. At least 14 days must have elapsed after discontinuation of prior cytotoxic chemotherapy before starting study drug.
-Prior immunotherapy (eg, anti-PD-1, anti-PD-L1, anti-TIM3, and anti-OX40) is allowed
-Subjects with advanced solid tumors harboring ALK, ROS1, NTRK1, NTRK2, or NTRK3 rearrangements are eligible. There is no limit to the number of prior chemotherapy, immunotherapy, or TKI regimens.
Exclusion Criteria:
-Concurrent participation in another therapeutic clinical trial.
-Symptomatic brain metastases or leptomeningeal involvement.
-History of previous cancer requiring therapy within the previous 2 years except for squamous cell or basal-cell carcinoma of the skin.
-Major surgery within 4 weeks of start of Reprotrectinib treatment. Radiation therapy within 2 weeks of study entry.
-Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment).
Study Contact:
Lisa Wahowske, RN
(651) 254-1517
lisa.wahowske@parknicollet.com
A Phase 1b/2 Open label, Dose Escalation and Expansion Study of Glutaminase Inhibitor Telaglenastat (CB-839) in Combination with CDK4/6 Inhibitor Palbociclib in Patients with Advanced or Metastatic Solid Tumors (CX-839-012) This study is on hold until further notice.
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Calithera Biosciences, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of this study is to determine a safe and tolerable dose of telaglenastat (the study drug), given together with Palbociclib (an FDA approved drug), and if it has an effect on non-small cell lung cancer or colorectal cancer. Telaglenastat has been shown to stop the growth or kill cancer cells in a variety of different types of tumors. Telaglenastat and Palbociclib combination therapy has been studied in pre-clinical studies and has been shown to have a benefit in the reduction of cell growth.
Inclusion Criteria:
- Incurable/locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy OR
Incurable/locally advanced or metastatic KRAS-mutant NSCLC previously treated with systemic chemotherapy
including platinum-based and anti-PD-1/PDL-1 therapy. - Must have available archival tissue block or slides. If archival tissue is not available, must be willing to undergo a fresh tissue biopsy procedure.
- ECOG Performance Status of 0-1.
Exclusion Criteria:
- Prior treatment with CB 839 or palbociclib.
- Active and/or untreated CNS metastasis.
- Infection requiring more than 5 days of parenteral antibiotics, antivirals, or anti-fungals within 2 weeks prior to cycle 1 day 1.
- Unable to discontinue proton pump inhibitor use prior to study treatment.
- Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption.
- Major surgery within 28 days prior to first dose of study drug.
- Receipt of any anticancer therapy within the following windows:
- Small molecule TKI therapy (including investigational) within 2 weeks or 5 half-lives prior to expected Cycle 1 Day 1 dose.
- Any type of anti-cancer antibody or cytotoxic chemo within 4 weeks prior to Cycle 1 Day 1 Dose.
- Radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to Cycle 1 Day 1 Dose.
- Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
A Phase II Trial of Atezolizumab and Bevacizumab in Cisplatin-ineligible Subjects with Advanced/Unresectable Urothelial Cancer (GU15-215)
Principal Investigator: Arek Dudek, MD, PhD
Study Sponsor: Hoosier Cancer Research Network
Location: Regions Cancer Care Center (Regions Hospital)
Phase of Study: Phase 2
Purpose of Study:
The purpose of this study is to evaluate any good and bad effects of treating your different types of urothelial cancer with atezolizumab plus bevacizumab. Atezolizumab is already an FDA approved treatment for advanced urothelial cancer for people who cannot safely receive cisplatin chemotherapy, and this study will assess the effect (good or bad) of adding bevacizumab to atezolizumab. Bevacizumab is not FDA approved standard treatment for urothelial cell carcinoma. In this study, you will receive atezolizumab plus bevacizumab as the first treatment for your advanced urothelial cancer. Bevacizumab plus atezolizumab has been shown to be safe in previous studies in patients with other type of cancers. The study doctors would like to determine if the combination of atezolizumab and bevacizumab is more effective in controlling your cancer.
Inclusion Criteria:
– Age ≥ 18 years.
– ECOG Performance Status 0, 1 or 2 within 28 days prior to randomization.
– Histologic or cytological evidence of urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra.
– Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease.
– Willing to undergo a core needle or excisional biopsy on-treatment.
Exclusion Criteria:
– Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment.
– Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment.
– Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments.
– Leptomeningeal disease.
– Uncontrolled tumor-related pain.
– Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
AB928CSP002: A Phase I/Ib Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Breast and Gynecologic Malignancies (AB928CSP002)
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study sponsor: Arcus Biosciences, Inc.
Locations: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This study will help us understand whether a potential new treatment, AB928, can be safely given in combination with chemotherapy to subjects with cancer. AB928 will be evaluated in combination with a chemotherapy treatment Pegylated liposomal doxorubicin (PLD) or nanoparticle albumin-bound (nab)- paclitaxel (NP) with or without another experimental drug called IPI-549. AB928 and IPI-549 are considered investigational and are not approved by the U.S Food and Drug Administration (FDA).
Inclusion Criteria:
– Female participants ≥ 18 years of age at the time of screening.
– Women with no childbearing potential because of surgery or at least 1 year post-menopause, or menopause confirmed by follicle-stimulating hormone testing.
– Must have at least 1 measurable lesion per RECIST v1.1.
– ECOG performance status score of 0 or 1.
– Must have archival tissue sample available for donation.
Exclusion Criteria:
– Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
– Underlying medical conditions that, in the Investigator’s or Sponsor’s opinion, will make the administration of investigational product hazardous (eg, interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs, or concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids.
– Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
– Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 30 days after the last dose of investigational product regimen.
– Baseline QT interval corrected with Fridericia’s method (QTcF) > 480 ms (average of triplicate readings).
Study Contact:
Lisa Wahowske, RN BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
ALK4230-001: A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors (ARTISTRY-2)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Alkermes, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to assess the safety and identify the recommended dosing of an experimental drug called ALKS 4230 alone or in combination with a drug that has been approved by the FDA called KEYTRUDA® (pembrolizumab). Eligible patients will be those who have a solid tumor that is resistant to some or all of the available standard treatments, or for which no standard treatment is available.
Inclusion Criteria:
For Part A the subject has histological or cytological evidence of a solid tumor. For Part B the subject must have 1 of the unspecified adult solid tumor types defined in the protocol.
- Record of programmed cell death ligand 1 protein expression status, or availability of fresh or archival tumor tissue for cellular characterization and PD-L1 status.
- Subjects must have adequate liver function.
- Subjects must have adequate kidney function.
- Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery.
- Subjects who have received radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study.
- Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered.
- Subject will agree to follow contraceptive requirements defined in the protocol
- Additional criteria may apply.
Exclusion Criteria:
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Subjects with an active infection or with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing for Cycle 1
- Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks, and the subject is neurologically stable
- Subjects with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
- Subjects who require pharmacologic doses of steroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
- Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
- Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects to cooperate and participate in the study
- The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
ARRAY 818-103: A Sequential 2-arm, Open-label Phase 1 Study to Evaluate the Effects of Encorafenib in Combination with Binimetinib on the Pharmacokinetics of Losartan, Midazolam, Caffeine, Omeprazole, and Dextromethorphan Administered in a Cocktail Approach and on the Pharmacokinetics of Rosuvastatin in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors
Principal Investigator: Arek Dudek, MD, PhD
Study Sponsor: ARRAY Pharmaceuticals, Inc.
Location: Regions Cancer Care Center (Regions Hospital)
Phase of Study: Phase 1
Purpose of Study: To assess the effect of encorafenib and binimetinib (the study drugs) on the activity of other common drugs. This study will also look at the safety and how you tolerate the study drugs when administered with the other common drugs. These other common drugs are approved by the FDA and include losartan (a drug used to treat high blood pressure), dextromethorphan (a drug used to treat coughs), caffeine (about the same amount as a cup of coffee), omeprazole (a drug used to treat upset stomach), midazolam (a drug used as a sedative), and rosuvastatin (a drug used to treat high cholesterol).
The study drugs are investigational study drugs, meaning that they have not been approved by the United States Food and Drug Administration (FDA).
Inclusion Criteria:
– Male or female patient, age ≥ 18 years;
– Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma AJCC Stage IIIB, IIIC or IV; or other BRAF V600-mutant advanced solid tumors;
– Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to enrollment, as determined locally using an approved test;
– Evidence of measurable or non-measurable lesions as detected by radiological or photographic methods according to guidelines based on RECIST v. 1.1;
– Patient with unresectable locally advanced or metastatic melanoma who has received no prior treatment or progressed on or after prior systemic therapy. Note: Prior therapy with a BRAF inhibitor (e.g., vemurafenib,dabrafenib, encorafenib and XL281/BMS-908662) and/or a MEK inhibitor (e.g., trametinib, binimetinib, selumetinib, cobimetinib and refametinib) is permitted except in the regimen immediately prior to study entry. Progression during prior BRAF/MEK inhibitor treatment is not required;
– Patient with other (non-melanoma) BRAF V600-mutant advanced solid tumors who has progressed on standard therapy or for whom there are no available standard therapies. Note: Prior therapy with a BRAF inhibitor and/or a MEK inhibitor is permitted except in the regimen immediately prior to study entry.
Exclusion Criteria:
– Symptomatic brain metastasis. Patients previously treated or untreated for these conditions who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases must be stable, with imaging (MRI or CT) demonstrating no current evidence of progressive brain metastases at screening;
– History of reaction to any of the study medications being used in this trial;
– Use, within 2 weeks prior to the start of treatment (Day -14) and through DDI phase (Day 28), of any herbal medications/supplements or any medications or foods that are strong inhibitors or inducers of CYP3A4/5, strong inhibitors of UGT1A1 and substrates of CYP3A4, CYP2C9, CYP1A2, CYP2C19, CYP2D6, BCRP, P-glycoprotein (P-gp), organic anion transporters 1 and 3 (OAT1, OAT3), organic anion transporter 2 (OCT2), OATP1B1 and OATP1B3.
– Consumption of grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice of each starting from Day -14 and through the DDI phase (Day 28), due to potential CYP3A4 interaction with the study drugs. Orange juice is allowed;
– Symptomatic or untreated leptomeningeal disease;
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
ASTELLAS 8951-CL-0301 (Spotlight)
Recruitment paused due to COVID-19
Principal Investigator: Daniel Anderson, MD
Study sponsor: Astellas
Location: Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: A study to assess the efficacy of IMAB362 plus mFOLFOX6 compared with placebo plus mFOLFOX6 as first-line treatment of subjects with Claudin (CLDN) 18.2 positive, HER2-negative, locally advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (Spotlight).
Inclusion Criteria:
Waivers to the inclusion criteria will NOT be allowed.
– Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for US sites) must be obtained from the subject or legally authorized representative (if applicable) prior to any study-related procedures.
– Subject is considered an adult (e.g., ≥ 18 years of age in the US) according to local regulation at the time of signing the informed consent.
– Subject agrees not to participate in another interventional study while on study treatment.
– A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 12.3 Contraception Requirements OR
b. WOCBP who agrees to follow the contraceptive guidance as defined in Appendix 12.3 Contraception Requirements throughout the treatment period and for at least 6 months after the final study drug administration.
– Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study treatment administration.
– Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
– A sexually active male subject with female partner(s) who are of childbearing potential must agree to use contraception as detailed in Appendix 12.3 Contraception Requirements during the treatment period and for at least 6 months after the final study drug administration.
– Male subject must not donate sperm starting at Screening and throughout the study period and for 6 months after the final study drug administration.
– Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.
Disease Specific Criteria:
– Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
– Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
– Subject has measurable disease according to RECIST 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
– Subject’s tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
– Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
Physical or Laboratory Findings
– Subject has ECOG performance status 0 to 1.
– Subject has predicted life expectancy 12 weeks in the opinion of the investigator.
– Subject must meet all of the following criteria based on the centrally analyzed laboratory tests within 14 days prior to the first dose of study treatment. In case of multiple laboratory data within this period, the most recent data should be used to determine eligibility.
a. Hemoglobin (Hgb) ≥ 9 g/dL. NOTE: subject must not have received any growth factor or blood transfusions within 14 days prior to the hematology values obtained at screening. Subjects requiring transfusions to meet eligibility criteria are not eligible.
b. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
c. Platelets ≥ 100 x 109/L
d. Albumin ≥ 2.5 g/dL
e. Total bilirubin < 1.5 x upper limit of normal (ULN)
f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
g. Estimated creatinine clearance ≥ 30 mL/min
h. PT/international normalized ratio (INR) and PTT ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)
Exclusion Criteria:
Waivers to the exclusion criteria will NOT be allowed.
Subject who meets any of the following exclusion criteria prior to enrollment is not eligible for enrollment:
Prohibited Treatment or Therapies
– Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to first dose of study treatment.
– Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was completed >28 days prior to start of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases ≥14 days prior to start of study treatment and has recovered from all acute toxicities is allowed.
– Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) or a single dose of systemic corticosteroids are allowed.
– Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment.
Medical History or Concurrent Disease
– Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
– Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
– Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.
– Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)
– Subject has gastric outlet syndrome or persistent/recurrent vomiting.
– Subject with recent gastric bleeding or symptomatic subjects with proven gastric ulcers that would exclude the subject from participation per investigator judgment.
– Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive HBs Ag) or C infection. For subjects who are negative for HBs Ag, but HBc Ab positive, an HB DNA test will be performed and if positive the subject will be excluded. Subjects with positive serology but negative HCV RNA test results are eligible.
– Subject has an active autoimmune disease that has required systemic treatment within the past 2 years.
– Subject has active infection requiring systemic therapy that has not completely resolved within 14 days prior to start of study treatment.
– Subject has significant cardiovascular disease, including any of the following:
a. Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to administration of first dose of study drug.
b. History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
c. QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
d. History or family history of congenital long QT syndrome
e. Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to first dose of study drugs are eligible)
– Subject has known active central nervous system metastases and/or carcinomatous meningitis.
– Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
– Subject has had a major surgical procedure 28 days prior to the start of study treatment.
a. Subject is without complete recovery from a major surgical procedure 14 days prior to the first dose of study treatment.
– Subject has psychiatric illness or social situations that would preclude study compliance, per investigator judgment.
– Subject has another malignancy for which treatment is required per investigator’s clinical judgment.
– Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
Act Fast ExSc 2018-07
Recruitment paused due to COVID-19
Principal Investigator: Dylan Zylla, MD
Study sponsor: Exact Sciences
Location: Frauenshuh Cancer Center
Purpose of study: Blood and Stool Sample Collection in Subjects with a Diagnosis of Colorectal Cancer or Colorectal Lesion.
Inclusion Criteria:
-Subject is male or female, 40 years of age or older.
-Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy or a colorectal lesion at least 1 cm in size suspicious for adenoma (including sessile serrated adenoma) or CRC on a pre-enrollment colonoscopy.
-Post-colonoscopy, the residual lesion in the colon must be at least 1 cm in size as to require additional surgical excision or complex colonoscopic polypectomy.
-Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
-Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
-Less than 7 days between colonoscopy and blood and stool sample collection.
-IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood and/or stool collection.
-Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Study Contact:
Monaline Santa Ana
(952) 993-6723
Monalina.Santaana@parknicollet.com
Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Recruitment paused due to COVID-19
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Celgene Corporation
Location: Frauenshuh Cancer Center (Methodist Hospital)
Phase of Study: Phase 3
Purpose of Study: There are three main purposes of this study: (1) To use the information collected to better understand patterns of diagnosis, treatment and outcomes, including disease progression and survival, in patients with MDS and AML; (2) To use the information to better understand patterns of quality of life in patients newly diagnosed with lower-risk MDS, higher-risk MDS, ICUS [Idiopathic Cytopenia of Undetermined Significance] or AML; and (3) To use the results of this study to provide information to better understand the effects of different treatments on a patient’s disease and quality of life. This study does not involve any treatment. Any current treatment will not be affected by participation in this registry study.
Study Contact:
Amy Feist
(952) 993-6071
Amy.Feist@parknicollet.com
DF6002-001: A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination with Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Dragonfly Therapeutics, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of this study is to test the levels of the investigational medicine, DF6002, in your blood, the safety of DF6002, and how people with solid tumor cancers respond to the investigational medicine both by itself as well as in combination with Keytruda (pembrolizumab).
DF6002 is a type of protein that binds to immune receptors which produce an immune response. It is not approved by the FDA. Keytruda is already approved for the treatment of multiple types of solid tumors, but the Sponsor is interested in understanding how the study drug investigational medicine works when given together with Keytruda.
Inclusion Criteria:
– At least 18 yeas of age.
– Histologically or cytologically proven locally advanced or metastatic solid tumors for which no standard therapy exists, or standard therapy has failed.
– ECOG performance status of 0-1.
– Clinical or radiological evidence of disease.
– Adequate hematological, hepatic, and renal function.
– Other criteria may apply depending on tumor type.
Exclusion Criteria:
– Concurrent treatment with a non-permitted drug.
– Prior treatment with rhIL2 or any recombinant long acting drug containing an IL2 moiety.
– Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [with the exception of palliative bone directed radiotherapy], immune therapy, or cytokine therapy except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment.
– Previous malignant disease other than the target malignancy to be investigated in this study within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ.
– Rapidly progressive disease.
– Active or history of central nervous system (CNS) metastases.
– Receipt of any organ transplantation including autologous or allogeneic stem-cell transplantation.
– Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
Exact Sciences 2018-01
Recruitment paused due to COVID-19
Principal Investigator: Rachel Lerner, MD
Study sponsor: Exact Sciences
Location: Frauenshuh Cancer Center
Purpose of study: The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
Inclusion Criteria:
-Subject is male or female > 18 years of age.
-Subject has an untreated primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
-Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
Exclusion Criteria:
-Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
-Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
-Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection.
-Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
-Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
-IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
-Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Study Contact:
Grace Gilmore
(952)993-1737
Grace.Gilmore@parknicollet.com
GNX-001: A Phase I Study of GNX102 in patients with Advanced Solid Tumors
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: Glyconex, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purposes of this study are to determine the right dose of GNX102 that can be tolerated by people with cancer, and, to see if it can shrink the tumors. GNX102, is an antibody that binds to a certain target on the surface of the cancer cells. This target has been shown to be present on the surface of many different types of tumors. When this study medication binds to this target it is thought that it may kill the cancer cells.
Eligible patients will be those that have cancer that has continued to grow despite having tried many different treatments.
Inclusion Criteria:
– Must be at least 18 years of age.
– Must have histologially confimred solid tumor with a likelihood of expression of GNX102 targeted antigens (for example: colorectal, hepatocellular, non-small cell lung, gastric, breast, bladder, pancreatic, melanoma, esophageal, prostate, ovarian, cervical, and epithelial uterine cancers).
– Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit.
– ECOG performance status of 0-1
– Acceptable liver, renal, and hematologic function (as determined by blood tests).
– Acceptable coagulation status.
– Life expectancy of at least 3 months.
– Other criteria may apply.
Exclusion Criteria:
– Has any other malignancy.
– Has a positive PCR test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a negative PCR test.
– Has New York Heart Association Class III or IV heart disease.
– History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months.
– History of cerebral vascular accident or transient ischemic attack within the past 6 months.
– History of primary CNS tumor.
– History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Patients with meningeal carcinomatosis are excluded regardless of treatment.
– Active, nonmalignant gastrointestinal (GI) disease requiring treatment (such as inflammatory bowel disease, Crohn’s disease, colitis) that would impart excess risk associated with study participation or study drug administration
– Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
LUN18-357: Induction Durvalumab Followed by Chemoradiation and Consolidation Durvalumab (MEDI4736) for Stage III Non-small Cell Lung Cancer
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: AstraZeneca, Hoosier Cancer Research Network
Location: Frauenshuh Cancer Center, Regions Cancer Care Center
Phase of Study: Phase 2
Purpose of study: The purpose of the study is to find out if adding durvalumab prior to chemoradiation (induction) will make your cancer respond better than the usual approach. The usual approach is defined as care most people get for stage 3 non-small cell lung cancer.
Inclusion Criteria:
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1.
- Histological or cytological confirmation of stage III non-small cell lung cancer, eligible for curative-intent concurrent chemoradiation. NOTE: subjects are not candidates for surgical resection either due to medical inoperability or surgically unresectable disease
- Measurable disease according to RECIST 1.1 criteria.
- Plan for treatment with concurrent chemoradiation with a dose of radiation ranging from 54-66 Gy
- Have adequate organ function as determined by standard blood tests.
- Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration.
- Life expectancy of at least 12 weeks per investigator discretion.
- Other criteria may apply.
Exclusion Criteria:
- Prior therapy for stage III NSCLC. Mixed histology with small cell lung cancer will not be allowed.
- Sequential chemoradiation will not be permitted.
- Induction and consolidation chemotherapy (separate from concurrent chemoradiation) will not be allowed.
- Prior exposure to anti-PD-1 or anti-PD-L1 antibodies including durvalumab.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. Some exceptions apply.
- History of pulmonary fibrosis, interstitial lung disease, or pneumonitis requiring steroids.
- Active or prior documented autoimmune disease within the last 2 years. Patients with vitiligo, stable hypothyroidism, Grave’s disease, or psoriasis not requiring systemic treatment are not excluded.
- Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, COPD, allergic rhinitis).
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.
- Active other malignancy; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer.
- History of organ transplantation (including allogeneic stem cell transplantation).
- Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
MEL18-372: Phase 1B/2 Study of PAC-1 and Entrectinib for Patients with Metastatic Uveal Melanoma
Principal Investigator: Yan Ji, MD, PhD
Study Sponsor: Vanquish Oncology, Inc., Genentech, Inc., HealthPartners Institute
Location: Frauenshuh Cancer Center, Regions Cancer Care Center
Phase of Study: Phase 1b/2
Purpose of study: There are two parts to this study. The purpose of the first part of the study (Phase 1b) is to assess the highest and safest dose of PAC-1 (experimental drug) in combination with entrectinib. The purpose of the second part of the study (Phase 2) is to test the effectiveness and safety of an experimental drug, PAC-1, in combination with entrectinib, by evaluating how well the combination keeps your cancer from being active and side effects of the treatment combination.
There is one ongoing study that is testing PAC-1 in humans. Entrectinib is approved by the Food and Drug Administration (FDA) for uses in other types of cancer. The use of entrectinib for metastatic uveal melanoma is considered investigational. “Investigational” means that the FDA has not approved this drug alone or in combination with PAC-1 for your type of cancer. If you choose to participate, you will be asked to sign the consent form. There are 4 study periods.
Inclusion Criteria:
- Age ≥ 18 years at the time of consent.
- Histologically or cytologically confirmed metastatic uveal melanoma.
- One or more lesions that could be accurately measured using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Demonstrate adequate organ function as defined by standard blood tests.
- Subjects must have archival tissue (metastatic disease preferred) available or undergo a biopsy prior to Cycle 1 Day 1 of treatment. Subjects that do not have archival tissue or cannot undergo a biopsy are not eligible for the study.
- Prior therapy is allowed but must have been completed 21 days prior to initiation of protocol therapy and all toxicities must be < Grade 2.
- Palliative radiation must have been completed 2 weeks prior to the initiation of study therapy.
- Patient with known brain metastases must have been treated at least 2 weeks prior to enrollment, be asymptomatic from brain metastases, stable on brain imaging, and not be receiving a supra-physiologic dose of steroids (>10 mg prednisone daily or equivalent).
- Other criteria may apply.
Exclusion Criteria:
- Peripheral sensory neuropathy
- Active gastrointestinal disease (e.g., Crohn’s disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact drug absorption.
- Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), and/or Hepatitis B or C
- Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. NOTE: Radiation-induced lung disorders are not included in this exclusion criterion.
- History of retinal pigmented epithelial detachment, central serous retinopathy, or retinal vein occlusion in the unaffected eye; or intraocular pressure 21 mmHg or uncontrolled glaucoma (irrespective of intraocular pressure) in the unaffected eye.
- History of uncontrolled seizures.
- History of ataxia.
- Thromboembolic events requiring therapeutic anticoagulation. Concomitant anticoagulation with oral anticoagulants (warfarin, direct thrombin or factor Xa inhibitors), platelet inhibitors (e.g. Clopidogrel, high dose aspirin) is prohibited. Low-dose aspirin (<100 mg/day), low-dose warfarin (<1 mg/day) and prophylactic low molecular weight heparin (LMWH) or similar agent are permitted.
- History of recent (within the past 3 months) symptomatic congestive heart failure or cardiovascular disorders
- Known uncontrolled, symptomatic brain metastasis or cranial epidural disease.
- Other criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
MRTI NSCLC SITRA NIVO (MRT516-005 (MIRATI))
Principal Investigator: Rachel Lerner, MD
Study Sponsor: Mirati Therapeutics, INC
Location: Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of Study: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy in combination with checkpoint inhibitor therapy.
Inclusion Criteria:
-Diagnosis of Non-Squamous Non-Small Cell Lung Cancer.
-Receipt of prior first-line treatment with platinum-based chemotherapy in combination with PD-1/PD-L1 checkpoint inhibitor therapy.
-Adequate bone marrow and organ function.
-Candidate to receive docetaxel as second line therapy.
Exclusion Criteria:
-Uncontrolled brain metastases.
-Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions.
-Unacceptable toxicity with prior checkpoint inhibitor therapy.
-Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy in the first-line setting.
-Impaired heart function.
Study Contact:
Alissa Gavenda
(952) 992-5705
Alissa.Gavenda@parknicollet.com
Mayo Clinic MC17C1
Recruitment paused due to COVID-19
Principal Investigator: Dylan Zylla, MD
Study sponsor: Mayo Clinic
Locations:
-Frauenshuh Cancer Center
-Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
Inclusion Criteria:
-Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted).
-Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart? 14 days of registration and continue for at least 28 days.
-Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided).
-Patient must complete baseline quality of life (QOL) packet.
Exclusion Criteria:
-Patient has a prior allergy or intolerance of ketoconazole.
-Patient has an allergy or intolerance to sulfites.
Study Contact:
Monaline Santa Ana
(952) 993-6723
Monaline.Santaana@parknicollet.com
Merck LEAP 007
Principal Investigator: Daniel Anderson, MD
Study sponsor: Merck Sharpe and Dohme Corp
Location: Frauenshuh Cancer Center
Phase: Phase 3
Purpose of study: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in the treatment in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
Inclusion Criteria:
– Has a histologically or cytologically confirmed diagnosis of NSCLC.
– Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC]).
– Has measurable disease based on RECIST 1.1.
– Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression in ≥1% of tumor cells (Tumor Proportion Score [TPS] ≥1%) as assessed by immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central laboratory.
– Has a life expectancy of ≥3 months.
– Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study treatment but before randomization.
– Male participants must agree to the following during the treatment period and for at least 120 days after the last dose of study treatment: 1.) Must be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR 2.) Must agree to use study-approved contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) AND 3.) Must refrain from donating sperm for at least 120 days after the last dose of lenvatinib.
– Female participants are eligible if they are not pregnant or breastfeeding, and ≥1 of the following conditions applies: 1.) Is not a WOCBP OR 2.) Is a WOCBP and using a study-approved contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the treatment period and for at least 120 days after the last dose of study treatment.
– Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization.
– Has adequate organ function.
Exclusion Criteria:
– Has known untreated central nervous system metastases and/or carcinomatous meningitis.
– Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for ≥3 years since initiation of that therapy. (Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.)
– Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
– Has had an allogeneic tissue/solid organ transplant.
– Has a known history of human immunodeficiency virus (HIV) infection.
– Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
– Has a known history of hepatitis B or known active hepatitis C virus infection.
– Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral study drug absorption.
– Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as a history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident/stroke, or cardiac arrhythmia associated with hemodynamic instability.
– Has not recovered adequately from any toxicity and/or complications from major surgery before starting study treatment.
– Has a known history of active tuberculosis (TB).
– Has an active infection requiring systemic therapy.
– Has previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity or intolerance to any component of lenvatinib or pembrolizumab.
– Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
– Has received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC.
– Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]) or has received lenvatinib as monotherapy or in combination with anti- programmed cell death protein (anti-PD-1) agents.
– Has received radiotherapy within 14 days before the first dose of study treatment or received lung radiation therapy of >30 Gray (Gy) within 6 months before the first dose of study treatment. (Note: Participants must have recovered from all radiation-related toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation pneumonitis.)
– Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days before the first dose of study treatment.
– Is receiving systemic steroid therapy (doses >10 mg daily of prednisone equivalent) within 7 days before the first dose of study treatment.
– Has received a live vaccine within 30 days before the first dose of study treatmen.
Study Contact:
Amy Feist
(952) 993-6071
Amy.Feist@ParkNicollet.com
NATALEE TRIO033 (NATALEE)
Principal Investigator: Rachel Lerner, MD
Study Sponsor: Novartis
Location: Frauenshuh Cancer Center
Phase of Study: Phase 3
Purpose of study: A phase III multi center, randomized, open label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2 – early breast cancer.
Inclusion Criteria:
– Patient is ≥ 18 years-old at the time of PICF signature
– Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant ET (whichever occurs earlier), or male.
– Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
– Patient has breast cancer that is positive for ER and/or PgR
– Patient has HER2-negative breast cancer
– Patient has available archival tumor tissue from the surgical specimen
– Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III)
– If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
– If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
– Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years
Exclusion Criteria:
– Patient has received any CDK4/6 inhibitor
– Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk (“chemoprevention”) of breast cancer and/or treatment for osteoporosis within the last 2 years prior to PICF signature
– Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
– Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
– Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
– Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
– Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
– Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before PICF signature
– Patient has known HIV infection, Hepatitis B or C infection
– Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
– Patient is currently receiving any of the following substances within 7 days before randomization – Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
– is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment
– Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
– Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
– Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
– Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
NEKTAR PROPEL 16-214-05 A Phase 1b Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of NKTR-214 in Combo with Anti-PD1 (Pembro) or Anti-PDL1 (Atezolizumab) in Patients with Locally Advanced or Metastatic Solid Tumors
Principal Investigator: Rachel Lerner, MD
Study Sponsor: Nektar Therapeutics
Location: Frauenshuh Cancer Center
Phase of Study: Phase 1
Purpose of Study:
To test the safety, tolerability, and effectiveness (how well these drugs work together) of NKTR-214 given in combination with pembrolizumab or atezolizumab. We want to find out what effects, good or bad, the study drug has on you and your cancer when combined with pembrolizumab or atezolizumab.
NTKR-214 is a modified (changed in the laboratory) form of a protein called interleukin-2 (or IL-2) which is normally made by your immune system. This protein is designed to trigger (wake up) other cells in your immune system to start attacking your cancer cells. IL-2 has been used for certain cancers for many years so doctors understand many of the risks and benefits.
Pembrolizumab and atezolizumab are prescription medicines used to treat locally advanced or metastatic (has spread into different areas of the body) melanoma, locally advanced or metastatic urothelial bladder cancer or metastatic Stage 4 Non-small cell lung cancer (IV-NSCLC). They are antibodies (known as checkpoint inhibitors) that block a type of protein (PD-1 or PD-L1) that can prevent human immune cells (called T cells) from attacking cancer cells. Pembrolizumab blocks PD-1, and atezolizumab blocks PD-L1.
Inclusion Criteria:
– Histologically confirmed locally advanced melanoma (pembrolizumab only), locally advanced or metastatic urothelial carcinoma, or metastatic NSCLC.
– Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
– Life expectancy > 12 weeks as determined by the Investigator.
– Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
– Measurable disease per RECIST 1.1.
– Patients must not have received prior oncology regimens, including but not limited to inhibitors such as anti PD-1, anti-PD-L1, anti-PD-L2, anti CD137, or anti CTLA-4 (cytotoxic T lymphocyte-associated protein 4) antibody, or any other antibody or drug specifically targeting T cell co stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies.
– MELANOMA patients: must have histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system
– MELANOMA patients: Ocular melanoma is excluded
– MELANOMA patients: Have not received prior anti-cancer therapy for advanced or metastatic melanoma
– MELANOMA patients: Patients with unknown BRAF mutation status may enroll so long as mutation testing is planned to be performed within 30 days of Cycle 1 Day 1
– NSCLC patients: Histologically confirmed or cytologically confirmed diagnosis of stage IV NSCLC
– NSCLC patients: First-line (pembrolizumab only), patients must have high PD-L1 expression (Tumor Proportion Score [TPS] ≥ 50%) as determined by FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
– NSCLC patients: Second-line (pembrolizumab or atezolizumab), patients must have experienced disease recurrence or progression during or after a prior platinum-based chemotherapy given for advanced or metastatic disease. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations and must not have received chemotherapy.
– If patient is to receive pembrolizumab in combination with NKTR 214, PD L1 expression by TPS should be ≥ 1% as determined by an FDA-approved test.
– UROTHELIAL CARCINOMA patients: Histologically or cytologically documented locally advanced or metastatic urothelial carcinoma
– UROTHELIAL CARCINOMA patients: First-line (pembrolizumab only), patients who are not eligible for cisplatin-containing chemotherapy.
– UROTHELIAL CARCINOMA patients: First-line (atezolizumab only), patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy.
– UROTHELIAL CARCINOMA patients: Second-line (pembrolizumab or atezolizumab), patients who have disease progression during or following platinum-containing chemotherapy.
– Additional criteria may apply.
Exclusion Criteria:
– Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
– Females who are pregnant or breastfeeding.
– Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves’ disease, Hashimoto’s disease, alopecia areata, eczema, or with Medical Monitor approval).
– History of allergy or hypersensitivity to study drug components.
– Active malignancy not related to the current diagnosed malignancy.
– History of organ transplant that requires use of immune suppressive agents.
– Use of warfarin within 14 days of initiating study drug(s). (Note: Low molecular weight heparin is allowed on the study.)
– Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
– Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
– Additional criteria may apply
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
Neulasta On Pro
Recruitment paused due to COVID-19
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Amgen
Location: Frauenshuh Cancer Center (Methodist Hospital)
Purpose of Study: A Prospective Observational Study to Estimate the Incidence of Febrile Neutropenia (FN) Among Subjects With Non-myeloid Malignancies at High Risk for FN and Receiving Neulasta® (pegfilgrastim) Onpro® kit or Other Physician Choice Options for Prophylaxis of FN.
Study Contact:
Grace Gilmore
Grace.Gilmore@parknicollet.com
Phase II Study of Nivolumab and Ramucirumab for Patients with Previously-Treated Mesothelioma (LUN 15-299)
Principal Investigator: Arek Dudek, MD, PhD
Study Sponsor: Hoosier Cancer Research Network
Location: Regions Cancer Care Center
Phase of Study: Phase 2
Purpose of Study:
To assess whether the combination of immunotherapy and a drug that works to block the formation of new cancer blood vessels will stop the growth of mesothelioma. The current standard treatment for mesothelioma it to receive pemetrexed with a platinum-based chemotherapy. However, there is currently no standard treatment once pemetrexed in combination with a platinum-based chemotherapy is no longer working. People who are not in a study are usually treated with a different type of chemotherapy (vinorelbine, gemcitabine, or paclitaxel), immunotherapy, or with a drug that works to block the formation of new cancer blood vessels.
The immune system functions to protect your body against “foreign” invaders such as cancer by making special cells called T-cells. Over time cancer cells have developed a way to hide or camouflage themselves from the immune system by expressing a protein on their surface called PD-L1. When PD-L1 on the cancer cells binds to PD-1 on your immune system’s T-cells the immune system is turned off and no longer works to attack cancer cells. Nivolumab is an immunotherapy drug that works by blocking PD-1 receptor on T-cells from being able to bind PD-L1 released by cancer cells. This allows your immune system’s T-cells to recognize cancer cells as “foreign” and continue to attack the cancer cells.
Cancer, including mesothelioma, needs to make new blood vessels in order to survive and grow. People with advanced mesothelioma who are not in a study are sometimes treated with a class of drugs that block the formation of new blood vessels. These drugs are termed anti-angiogenic drugs. Two drugs in this class of medications are called bevacizumab and ramucirumab. Bevacizumab has been studied in mesothelioma, while ramucirumab has not.
Inclusion Criteria:
– Histologically-confirmed malignant mesothelioma not amenable to curative surgery and who have received at least one pemetrexed-containing chemotherapy regimen.
– Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
– Adequate blood counts and renal, bone marrow, and hepatic function
– Subjects on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH). Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices).
Exclusion Criteria:
– Any Grade 3-4 GI bleeding within 3 months prior to study registration.
– History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 3 months prior to study registration.
– Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to study registration.
– Cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis (any degree) with a history of hepatic encephalopathy, or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.
– Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
RGX-104-001: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies (RGX-104-001)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Rgenix, Inc. , Inc.
Location: Frauenshuh Cancer Center, Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if the experimental drug called RGX-104 used in combination with docetaxel, will help in the treatment of small cell lung cancer (SCLC). We are also testing RGX-104 in combination with pembrolizumab, carboplatin, and pemetrexed in patients with non-small cell lung cancer (NSCLC). We are trying to find the best dose to use that will benefit patients with SCLC or NSCLC.
Inclusion Criteria:
For patients with NSCLC enrolled in the pembrolizumab plus carboplatin/pemetrexed combination dose escalation or expansion stages:
- The patient must have histologic or cytologic evidence of newly-diagnosed non-squamous, NSCLC that is advanced disease, defined as cancer that is either metastatic (Stage 4) or locally advanced (Stage 3B) and unresectable.
- The patient has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
- The patient has not received prior systemic treatment for their advanced/metastatic disease.
- For patients in the expansion stage only: the patient’s tumor block must demonstrate PD-L1 expression TPS <1% as determined with a validated assay.
- The patient must have adequate organ function and performance status eligible for treatment with a platinum-based regimen and checkpoint inhibitor.
For patients with SCLC enrolled in the docetaxel combination expansion stage:
- The patient must have a pathologically confirmed (by histology or cytology) diagnosis of SCLC, which is currently extensive disease (disease outside a single radiation port), or of metastatic neuroendocrine cancer with small cell or high-grade features. Patients with metastatic neuroendocrine cancer with small cell or high-grade features must have a pathology report supplied to the sponsor before treatment.
- The patient must have demonstrated disease progression following platinum-based chemotherapy with or without a PD-1/L1 inhibitor for SCLC, or following a different, acceptable first-line regimen for high-grade neuroendocrine tumors.
- The patient must have received no more than 1 prior line of therapy for extensive disease.
Patients enrolled in the expansion stages must agree to a tumor biopsy to be obtained during the screening period and toward the beginning of Cycle 2 or at the time of PD, if earlier.
Patients must have disease that is measurable.
Patients must be ≥18 years old.
Patients must have a normal left ventricular ejection fraction as measured by an ECHO or MUGA
Additional criteria may apply.
Exclusion Criteria:
- Has persistent clinically significant toxicities (Grade ≥2) from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy and alopecia which are permitted). Prior toxicities that resulted in laboratory abnormalities should have resolved to Grade ≤1, unless a higher-grade abnormality is allowed by the inclusion criteria. If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.
- Has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study therapy administration
- Has received treatment with an investigational systemic anticancer agent within 14 days prior to study therapy administration.
- Has previously received treatment with RGX-104 or another investigational agent that is a known LXR agonist.
- Has clinically significant cardiovascular disease or uncontrolled, clinical significant pulmonary disease.
- Has known active or suspected brain or leptomeningeal metastases.
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
Seattle Genetics SGNTV – 01
Principal Investigator: Daniel Anderson, MD
Study sponsor: Seattle Genetics
Location: Frauenshuh Cancer Center
Phase of Study: Phase 2
Purpose of study: The primary goal of this global, open label, multicenter trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin every three weeks. Patients who meet eligibility criteria will be enrolled into one of 4 cohorts of tumor types known to express Tissue Factor. These include colorectal cancer, squamous non-small cell lung cancer (NSCLC), exocrine pancreatic adenocarcinoma, and squamous cell carcinoma of the head and neck (SCCHN).
Inclusion Criteria:
-Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous NSCLC, or SCCHN patients who are not candidates for standard therapy.
-All patients must have experienced disease progression on or after their most recent systemic therapy.
-Baseline measurable disease as measured by RECIST v1. 1.
-Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
-Colorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecean, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.
-Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment, a tyrosine kinase inhibitor, and a checkpoint inhibitor (CPI), if eligible. Patients should have received no more than 2 systemic regimens in the locally advanced or metastatic setting.
-Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
-Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the recurrent/metastatic setting.
Exclusion Criteria:
-Active bleeding conditions
-Ocular surface disease at the time of enrollment
-Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
-Uncontrolled tumor-related pain
-Peripheral neuropathy greater than or equal to Grade 2
-History of another malignancy within 3 years of the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
-Active or previous brain metastasis
-Patients who are breastfeeding, pregnant, or planning to become pregnant from the time of informed consent until 6 months after the final study dose is administered
-For patients with SCCHN or NSCLC, ongoing anticoagulant therapy
Study Contact:
Alissa Gavenda
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
Stellar-001 (Innate) – (INAT STELLAR001 P1 AST)
Principal Investigator: Dylan Zylla, MD
Study Sponsor: Innate Pharma SA
Location: Frauenshuh Cancer Center
Phase of Study: Phase I
Purpose of study: STELLAR-001: A phase I study of the anti-C5aR, IPH5401, in combination with the anti-PD-L1, durvalumab, in patients
with selected advanced solid tumors
Inclusion Criteria:
Patients must meet all of the inclusion criteria in order to be eligible to participate in the study.
1) Dose escalation: Patients with advanced and/or metastatic histologically confirmed HCC, UCC, RCC or NSCLC solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting. Patients should have received known standard therapies (including platinum-based chemotherapy in patients with UCC), unless not available or contraindicated.
2) Cohort expansion
i. NSCLC:
a. Histologically confirmed unresectable advanced and/or metastatic NSCLC
b. Patients should have been treated with no more than two lines of systemic therapies in the advanced/metastatic setting that include platinum based chemotherapy.
c. Patients should have received anti-PD1/anti-PD-L1 either as:
i. Single agent: In this case, patients should have had either RECIST response or stable disease for a minimum of 6 months before disease progression.
ii. In combination with first line platinum-based chemotherapy: In this case, patients should have had a RECIST response for a minimum of 6 months before disease progression.
ii. HCC:
a. Histologically confirmed unresectable advanced and/or metastatic HCC.
b. Child-Pugh Score Class A.
c. Patients should have been previously treated with no more than 2 lines of systemic therapy in the advanced/metastatic setting that should include sorafenib.
d. Patients should be naïve to treatment with anti-PD1/anti-PD-L1 therapy.
3) At least 18 years of age.
4) ECOG performance status of ≤1.
5) Adequate organ function defined as:
a. Hematological
i. Absolute neutrophilic count ≥ 1.5 x 109/L
a. For HCC ≥ 1.0 x 109/L
ii. Hemoglobin ≥ 9.0 g/dL
iii. Platelet count ≥ 75 x 109/L
b. Hepatic
i. Total bilirubin ≤ 1.5 x ULN
a. For HCC ≤ 2 x ULN
ii. AST and ALT ≤ 3 x ULN (and up to 5 x ULN in the presence of liver metastases)
iii. Albumin ≥ 3.3 g/dL (except for patients with HCC: albumin ≥ 2.8 g/dL)
iv. For HCC: INR < 1.7
c. Renal: calculated creatinine clearance (Cockcroft-Gault formula ≥ 50 mL/min
6) At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline.
7) Feasibility of obtaining tumor biopsy for patients included in the cohort expansion.
8) All AEs while receiving prior treatment with immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
9) No active viral hepatitis B or C.
a. Active hepatitis B is defined by HBV DNA and/or HBsAg positivity.
b. Active hepatitis C is defined by HCV RNA positivity.
10) Women of childbearing potential must have a negative serum or urine beta-HCG pregnancy test result within seven days of treatment and must practice an effective method of contraception during treatment and for at least 6 months (180 days) following the last dose of study drug
11) Male patients who are sexually active with a female partner of childbearing potential must agree to practice effective barrier contraception during treatment and for at least 6 months (180 days) following the last dose of study drug.
12) Ability to understand and the willingness to sign a written informed consent document.
13) A minimum life expectancy of 3 months.
14) Accept to comply with all procedures described in the protocol.
Exclusion Criteria:
Patients meeting any of the following exclusion criteria will not be eligible to participate in the study:
1) For patients with NSCLC:
a. Known actionable mutation or rearrangement (including but not limited to epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) gene rearrangements, ROS-1 alterations, or BRAF mutations).
2) For patient with Hepatocellular carcinoma:
a. Hepatic encephalopathy in the past 12 months.
b. Ascites that requires repeated paracentesis in the past 2 months.
c. Main portal vein thrombosis.
d. Active or prior history of gastrointestinal bleeding in the past 12 months.
e. Prior hepatic transplantation.
3) Patients with known spinal cord compression.
4) Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Patients with suspected CNS metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry to rule them out. Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
– Measurable disease, per RECIST v1.1, must be present outside the CNS.
– The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
– The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.
– The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anti-convulsant therapy at a stable dose is permitted.
5) Patients with tumors known to be microsatellite instable (i.e. MSI-High).
6) Prior treatment with systemic therapies that modulate myeloid derived suppressor cells (MDSCs), including but not restricted to anti-colony stimulating factor 1 (CSF-1).
7) Known allergic reactions attributed to compounds of similar product.
8) Patients with any serious underlying medical condition that would impair the patient from receiving or tolerating the planned treatment.
9) Concurrent enrollment in another clinical trial, unless it is an observational (non -interventional) clinical study or the follow-up period of an interventional study.
10) Any concurrent treatment with any anti-cancer therapy including but not restricted to chemotherapy, hormonal therapy, biological therapy or immunotherapy.
11) Systemic treatment with steroids or other immunosuppressive agents within 14 days prior to entry with the exception of intranasal, inhaled, or topical steroid, systemic prednisone at doses not exceeding 10 mg/day (or equivalent) or steroids as premedication for hypersensitivity reaction.
12) Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug
13) Active auto-immune disease within the past 2 years. Patients with vitiligo, alopecia, Grave’s disease, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded
14) History of adverse events that resulted in permanent discontinuation of prior immunotherapy.
15) ≥ Grade 3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy. Patients with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stable on appropriate replacement therapy and are asymptomatic. Immune-related AE would include dermatological (e.g. rash, eruptions), gastrointestinal (e.g. colitis, hepatitis, pancreatitis), endocrine (e.g. hypophysitis, thyroid or adrenal insufficiency), respiratory (e.g. pneumonitis), ocular (e.g., uveitis, conjunctivitis), neurological (e.g. paresthesia, myelitis), renal (e.g. renal failure), hematological (e.g. autoimmune cytopenia, red cell aplasia), or mucosal toxicities (e.g. oral mucositis, dry mouth).
16) Patients who have undergone major surgery <28 days prior to starting study drug.
17) Treatment with any conventional or investigational anticancer therapy within 28 days prior to first study product administration.
18) Primary immunodeficiency and/or history of allogenic bone marrow transplantation.
19) Current active infection.
20) Positive test results for human immunodeficiency virus.
21) Patients with a history of other active invasive malignancies during the past three years. Patients with history of other cancer > 3 years prior to enrollment could be enrolled provided that they are considered cured by their treating physician and are not receiving any form of “maintenance” therapy.
22) Pregnant or breastfeeding women.
23) Patients with abnormal cardiac history within 6 months before inclusion or with history of myocardial infarction.
24) Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
Study Contact:
Amy Feist
(952)993-6071
Amy.Feist@parknicollet.com
TAK 981-1002: A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics (PK) of TAK-981 in Adult Participants With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019 (COVID-19)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Takeda Pharmaceuticals
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of Study: The purpose of this study is to evaluate safety, tolerability and to identify the most appropriate dose of TAK-981 as treatment for patients with cancer. In addition, this study will also serve to obtain information on the amount of study drug in your blood after taking single and/or multiple doses of the study drug.
The main purposes of this study are:
– To determine if TAK-981 is safe in patients with cancer.
– To select the dose for future studies.
– To measure the amount of TAK-981 in your blood.
– To assess the anti-tumor effect of TAK-981.
– To assess how the research drug reaches its target protein (called SUMO activating enzyme). Small Ubiquitin-like
Modifier (or SUMO) proteins are proteins that attach and detach from other proteins. This happens in normal and
tumor cells to modify their function. SUMOylation is the process of adding these SUMO proteins to other proteins.
The process of SUMOylation allows growth of tumor cells, and prevents the immune system from attacking the
tumor. TAK-981 reduces SUMOylation, allowing the immune system to attack the tumor cells.
– To obtain information on how your body reacts to the study drug by looking at biomarkers. Biomarkers are
measurable substances that can be found in different tissues of your body like the blood, skin and the tumor.
– To determine if the amount of TAK-981 in your blood has any impact on your ECG results (heart function test).
TAK-981 is an investigational drug that has not yet been studied in humans. It has not been approved by the FDA (U.S. Food and Drug Administration) or other regulatory authorities for use by the general public. TAK-981 will be investigated in adult patients with metastatic solid tumors or lymphomas for which standard curative treatment or life-prolonging treatment does not exist, is no longer effective or if it cannot be tolerated or is not indicated for you.
Inclusion Criteria:
– Adult male of female patients >/= 18 years old.
– Eastern Cooperative Group (ECOG) performance status of 0 to 1.
– Patients with histologically confirmed advanced (local regionally recurrent not amenable to curative therapy) or metastatic solid tumors that have no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them, OR
– Patients with relapsed/refractory lymphoma not amenable to therapies with proven clinical benefit or who are intolerant or who refuse them. Patients with low-grade lymphomas such as follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, and marginal zone lymphomas may not need to exhaust all available therapy.
– Adequate bone marrow reserve and renal and hepatic function.
Exclusion Criteria:
– Treatment with systemic anticancer treatments or investigational products within 14 days before the first dose of study drug or 5 half-lives, whichever is shorter. Patients should have recovered from previous treatment toxicity to Grade 1, baseline (except alopecia and peripheral neuropathy), or the toxicity is considered established as a sequela.
– History of uncontrolled brain metastasis. Patients with brain metastases are allowed if they are previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery and the patients is receiving a corticosteroid dose ≤10 mg/day of prednisone equivalent at the time of receiving the first dose of TAK-981. For asymptomatic patients, screening brain imaging is not required.
– Patient has received extended field radiotherapy ≤4 weeks before the start of treatment (≤2 weeks for limited field radiation for palliation), and who has not recovered to grade 1 or better from related side effects of such therapy (except for alopecia).
– Patient is receiving any live vaccine (eg, varicella, pneumococcus) within 4 weeks of initiation of study treatment.
– History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of >Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
