HC366-RC2311: A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma
Principal Investigator: Brian Rank, MD
Study Sponsor: HiberCell Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This study is looking to test the safety and effectiveness, and to find the highest tolerated dose of study drug HC-7366 as single drug or in combination with Belzutifan (Welireg) in patients with Renal Cell Carcinoma. The study has two parts – a dose escalation phase (Finding the highest tolerated dose), and a dose expansion phase (further testing at the highest dose). The study drug works by interfering with cancer cells’ ability to feed themselves and potentially prevent their growth.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must have confirmed diagnosis of metastatic Renal Cell Carcinoma.
– Must have progressive disease after receiving at least 2, and no more than 5 prior therapies for stage 4 disease.
– Must have at least 1 measurable lesion per RECIST 1.1.
– Has no RCC tumor that requires immediate surgery.
– If reasonably accessible with minimal risk and patient willing, at least one biopsy at baseline and another at cycle 2 day 1.
– Must have ECOG of 0-1.
– Has adequate organ function as determined by lab tests.
– Must not experience more than 10% weight loss in the last 4 weeks prior to starting study drug.
– Must have at least a 3-month life expectancy as determined by treating physician.
– If female patient of childbearing potential, must agree to highly contraceptive method or maintain abstinence from intercourse during the trial period and at least 90 days following the last dose of study drug. Also must have negative serum pregnancy test at screening.
– Male patients must abstain from intercourse or agree to using highly contraceptive methods during trial period and at least 90 days after the last dose of study drug.
– Additional inclusion criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Patient is excluded if they have had prior treatment with Belzutifan or other HIF-2α inhibitor.
– Has received any type of small molecule kinase inhibitor within 2 weeks prior to study.
– Is currently receiving an investigational drug or device within 4 weeks prior to starting study.
– Has received radiotherapy within 2 weeks prior to study. Patient must have recovered from radiotherapy related toxicities and not require corticosteroids. A 1-week washout is required for palliative radiation to non-Central Nervous System disease.
– Is immunodeficient or receiving systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Has any of the following: Pulse oximeter reading of <92%, requires intermittent supplemental or chronic supplemental oxygen.
– Has history of lung disease or pneumonitis within 12 months prior to screening.
– Has clinically significant cardiovascular disease within 6 months from first study drug administration (specifics to be discussed with physician/study team).
– Has additional known malignancy that is progressing or has required active treatment within the last 5 years. Basal cell or squamous cell carcinoma are excluded. Other malignancies are also eligible if they were cured by surgery alone, surgery plus radiotherapy and have been disease free for at least 5 years.
– Has history of, or active central nervous system metastasis. May be able to participate if CNS is radiologically stable for at least 4 weeks and no evidence of enlargement.
– Has moderate to severe Child-Pugh B or C.
– Has known hypersensitivity to active ingredients of study drug or Belzutifan.
– Has history or retinitis or photosensitive skin disorders.
– Has history of severe autoimmune disease or history of organ transplant.
– Is unable to swallow oral medications or has evidence of GI disorder that may impact drug absorption.
– Has known active HIV or Hepatitis B or C.
– Is currently receiving strong or moderate Inducers or Inhibitors of Cytochrome P450 (CYP3A4) that cannot be discontinued during the study.
– Has a history of, or any other active condition that, in the opinion of the investigator, would interfere with the individual’s ability to cooperate with the study requirements.
– Other exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@parknicollet.com
MK-5684-004: A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Next generation Hormonal Agent (NHA)
Principal Investigator: Dylan Zylla, MD
Study sponsor: Merck Sharpe & Dohme LLC
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to test the safety and effectiveness of the study drug MK-5684 combined with hormone replacement therapy (HRT) compared to alternative Abiraterone acetate or Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
– Have histologically or cytologically confirmed adenocarcinoma of prostate without small cell histology.
– Have current evidence of metastatic disease documented either by bone lesions on bone scan, or by soft tissue disease documented by CT or MRI scan.
– Has prostate cancer progression while receiving androgen deprivation therapy.
– Has had disease progress during or after treatment with one next-generation hormonal agent.
– Has ECOG of 0 – 1.
– Has adequate organ function as determined by lab tests.
– Has provided tumor tissue from fresh core or excisional biopsy from soft tissue that was not previously radiated.
– Participants that test positive for Hepatitis B are eligible if they have received antiviral therapy for at least 4 weeks, and have undetectable load prior to randomization. Additionally, participants with Hepatitis C are eligible if viral load is undetectable at screening.
– HIV positive patients must be on well controlled antiretroviral therapy.
– Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Has other Gastrointestinal condition
– Unable to swallow capsules/tablets
– Has poorly controlled diabetes mellitus
– Has active or unstable cardio/Cerebro-vascular disease or thromboembolic events.
– Has significant abnormal sodium or potassium levels, or hypotension at screening.
– History or family history of long QTc Syndrome.
– Has history of seizures within 6 months prior to signing consent, or condition that may predispose to seizures within 12 months prior to signing consent.
– Has previously received Taxane-based chemotherapy or next-generation hormonal agent for metastatic castration-resistant prostate cancer.
– Has not recovered from previous major surgery or has ongoing surgical complications.
– Has received prior treatment with Radium for prostate cancer.
– Has received CYP450-inducing antiepileptic drugs for seizure.
– Has received radiotherapy within 2 weeks prior to first dose of study drug.
– Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study drug.
– Has received prior systemic therapy including other investigational drugs, or investigational devices within 4 weeks prior to first dose of study drug.
– Has received a live or live-attenuated vaccine within 30 days prior to first dose of study drug.
– Has known hypersensitivity to components or excipients in abiraterone acetate, prednisone or prednisolone, or enzalutamide.
– Has known other malignancy that is progressing or has required active treatment within the past 3 years.
– Is receiving chronic systemic steroid therapy (>10mg / day of prednisone or equivalent).
– Has known central nervous system metastases. Patients with previously treated brain Mets may participate if they have been radiologically stable for 4 weeks and have not required steroid treatment for at least 14 days prior to first dose of study drug.
– Has active autoimmune disease that required systemic treatment in the last 2 years.
– Has active infection that requires treatment.
– Has concurrent Hepatitis B and Hepatitis C virus infection.
– Additional criteria may apply and will be discussed with the study team and physician.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
