Status:
ACTIVE_NOT_RECRUITING
A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Prostatic Neoplasms
Metastatic Castration-Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 (mCRP...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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.
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2027
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06136598
Start Date
January 30 2024
End Date
March 14 2027
Last Update
December 16 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University First Hospital-Urology ( Site 0001)
Beijing, Beijing Municipality, China, 100034
2
Sun Yat-sen University Cancer Center-Neurosurgery department ( Site 0003)
Guangzhou, Guangdong, China, 510700
3
Tongji Hospital Tongji Medical,Science & Technology ( Site 0002)
Wuhan, Hubei, China, 430000