A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)

• Status: Recruiting
• Trial end date: 2027-10-14
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objectives of this study are to evaluate the safety and tolerability of opevesostat in the treatment of male Chinese participants with metastatic castration-resistant prostate cancer (mCRPC) and to characterize the pharmacokinetic profile of opevesostat. There are no formal hypotheses to be tested in this study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC
• Collaborator: Orion Corporation, Orion Pharma
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Fludrocortisone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Has histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.

• Has prostate cancer while receiving androgen deprivation therapy (ADT), or post-bilateral orchiectomy, within 6 months before screening.

• Has evidence of progression >4 weeks since last flutamide treatment or >6 weeks since last bicalutamide or nilutamide treatment.

• Has evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue shown by CT/MRI.

• Has disease that progressed during or after treatment with at least 1 line of next-generation hormonal agents (NHAs) for hormone-sensitive prostate cancer (HSPC) or castration-resistant prostate cancer (CRPC) for at least 8 weeks (at least 14 weeks for participants with bone progression).

• Has received at least 1 line of taxane-based chemotherapy for HSPC or CRPC and have had progressed disease during or on treatment, or refused or ineligible to receive chemotherapy.

• Has a life expectancy of >3 months.

Exclusion Criteria:

• Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.

• Has presence of gastrointestinal condition, e.g. malabsorption, that might affect the adsorption of study intervention.

• Has a history of pituitary dysfunction.

• Has poorly controlled diabetes mellitus.

• Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events.

• Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 4 weeks of the date of allocation.

• Has received an anticancer monoclonal antibody (mAb) within 4 weeks of allocation, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of allocation.

• Received prior systemic anticancer therapy including investigational agents within 4 weeks before the date of allocation.

• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any form of immunosuppressive therapy within 7 days prior to the start of study intervention.

• Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

• Has an active autoimmune disease that has required systemic treatment in the past 2 years.

• Has a history of or current human immunodeficiency virus (HIV) infection.

• Has a concurrent Hepatitis B or Hepatitis C virus infection.

• Has a history of allogenic tissue or solid organ transplant.