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
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
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
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
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
