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 Multicenter, Open-label, Phase 1a Study of HC 5404-FU in Subjects with Selected, Advanced Solid Tumors.
Principal Investigator: Arkadiusz Dudek, MD, PhD
Study Sponsor: HiberCell, Inc.
Location: Regions Cancer Care Center
Phase of Study: Phase 1
Purpose of study: This is a first-in-human study designed to establish the maximum tolerated dose, and to evaluate the safety and tolerability of oral drug HC-5404-FU in subjects with advanced solid tumors. Specific tumor types evaluated in this study are; renal cell carcinoma, gastric cancer, metastatic breast cancer, or small-cell lung cancer. HC-5404-FU is highly selective for protein kinase RNA-like endoplasmic reticulum kinase (PERK) and acts as a PERK inhibitor. PERK plays an important role in tumor growth and new blood vessel development, therefore interfering with PERK function could potentially lead to tumor growth inhibition.
Inclusion Criteria:
- Have a signed informed consent form (ICF) prior to any study-specific procedures or treatment
- Be ≥18 years of age (male or female) at the time of consent
- Have 1 of the following histologically or cytologically confirmed tumor types with qualifying characteristics, and have received a minimum of 3 (and no more than 5) lines of prior therapy for metastatic (Stage IV) disease:
a. RCC (renal cell carcinoma – clear cell or papillary)
b. GC (gastric adenocarcinoma)
c. Human epidermal growth factor receptor positive (HER2+) MBC
(metastatic breast cancer)
d. SCLC (small cell lung cancer) - Have at least 1 radiologically measurable lesion as per RECIST v1.1.
- Two biopsies will be necessary: at baseline (within 30 days prior to first dose) and within 7 days after Cycle 3/Day 1. Newly obtained biopsy specimens are preferred to archived samples, and formalin-fixed, paraffin-embedded block specimens are preferred to slides. In the event a fresh pre-treatment biopsy is not able to be provided, the most recent archival biopsy must be provided in its place.
- ECOG Status of 0 or 1.
- Have life expectancy of 3 months or greater as determined by the treating physician.
- Have adequate organ function within 15 days prior to first administration of dose.
- Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures.
- Additional criteria may apply and will be discussed in further detail with the physician.
Exclusion Criteria:
- Subject is currently pregnant, planning to become pregnant, or breastfeeding
- Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to the first dose of study treatment or who has not recovered from adverse reactions due to a previously administered agent or major surgery.
- Is currently participating in a clinical trial and is receiving treatment using an investigational drug or investigational device, or has received treatment using an investigational therapy within 4 weeks prior to first dose.
- Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- Has known history of active tuberculosis, history of HIV (HIV 1/2 antibodies), has known active Hepatitis B (anti-hepatitis B surface antibody, anti-hepatitis B core antibody, hepatitis B surface antigen [HBsAg]) or Hepatitis C (hepatitis C antibody) infection, history of clinically severe autoimmune disease, or a history of organ transplant.
- Has been diagnosed with severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infection and/or is seropositive for (SARS-CoV)-2 antibodies, as per the local guidelines at screening and is positive by 7 days prior to the first dose of study treatment.
- Has insulin-dependent (Type I) diabetes or poorly controlled Type II diabetes (per clinical discretion).
- Has known additional malignancy that is progressing or required active treatment within previous 5 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, superficial bladder cancer, or in situ cervical cancer. Subjects with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
- Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using systemic steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- Has a history of interstitial lung disease, pneumonitis within 12 months prior to screening or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a history or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, congestive heart failure, baseline ECG abnormalities, including, but not limited to, QTc prolongation (prolonged QTcF defined as ≥450 msec) or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.
- Has overt or latent disorders of the exocrine pancreas (such as acute or chronicpancreatitis of any etiology) or chronic (including autoimmune) gastrointestinal disorders such as Crohn’s disease, ulcerative colitis, rheumatoid arthritis, lupus, scleroderma, Sjogren’s syndrome, and polyarteritis nodosa.
- Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial.
- Additional exclusion criteria may apply and will be discussed with physician.
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 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
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
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
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
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
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
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
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
