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

Phase 1

Active, not recruiting

• Conditions: Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer

• Registration Number: NCT06136598
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

The main inclusion and exclusion criteria include but are not limited to the following:<br><br>Inclusion Criteria:<br><br> - Has histologically or cytologically confirmed adenocarcinoma of the prostate without<br> small cell histology.<br><br> - Has prostate cancer while receiving androgen deprivation therapy (ADT), or<br> post-bilateral orchiectomy, within 6 months before screening.<br><br> - Has evidence of progression >4 weeks since last flutamide treatment or >6 weeks<br> since last bicalutamide or nilutamide treatment.<br><br> - Has evidence of metastatic disease documented by either bone lesions on bone scan<br> and/or soft tissue shown by CT/MRI.<br><br> - Has disease that progressed during or after treatment with at least 1 line of<br> next-generation hormonal agents (NHAs) for hormone-sensitive prostate cancer (HSPC)<br> or castration-resistant prostate cancer (CRPC) for at least 8 weeks (at least 14<br> weeks for participants with bone progression).<br><br> - Has received at least 1 line of taxane-based chemotherapy for HSPC or CRPC and have<br> had progressed disease during or on treatment, or refused or ineligible to receive<br> chemotherapy.<br><br> - Has a life expectancy of >3 months.<br><br>Exclusion Criteria:<br><br> - Has history of a second malignancy, unless potentially curative treatment has been<br> completed with no evidence of malignancy for 3 years.<br><br> - Has presence of gastrointestinal condition, e.g. malabsorption, that might affect<br> the adsorption of study intervention.<br><br> - Has a history of pituitary dysfunction.<br><br> - Has poorly controlled diabetes mellitus.<br><br> - Has active or unstable cardio/cerebro-vascular disease, including thromboembolic<br> events.<br><br> - Has undergone major surgery, including local prostate intervention (except prostate<br> biopsy), within 4 weeks of the date of allocation.<br><br> - Has received an anticancer monoclonal antibody (mAb) within 4 weeks of allocation,<br> or has not recovered from adverse events (AEs) due to mAbs administered more than 4<br> weeks before the date of allocation.<br><br> - Received prior systemic anticancer therapy including investigational agents within 4<br> weeks before the date of allocation.<br><br> - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy<br> (in dosing exceeding 10 mg daily of prednisone equivalent) or any form of<br> immunosuppressive therapy within 7 days prior to the start of study intervention.<br><br> - Has a known active central nervous system (CNS) metastases and/or carcinomatous<br> meningitis.<br><br> - Has an active autoimmune disease that has required systemic treatment in the past 2<br> years.<br><br> - Has a history of or current human immunodeficiency virus (HIV) infection.<br><br> - Has a concurrent Hepatitis B or Hepatitis C virus infection.<br><br> - Has a history of allogenic tissue or solid organ transplant.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE);Number of Participants Who Discontinue Study Intervention Due to an AE;Maximum Plasma Concentration (Cmax) of opevesostat;Time to Maximum Plasma Concentration (Tmax) of opevesostat;Area Under the Curve from Time 0 to 12 hours postdose (AUC0-12) of opevesostat;Apparent Volume of Distribution (Vz/F) of opevesostat;Oral Clearance (CL/F) of opevesostat;Half-Life (t1/2) of opevesostat

Secondary Outcome Measures

Name	Time	Method
Prostate-specific Antigen (PSA) Response Rate;Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);Objective Response Rate (ORR) Per PCWG-modified RECIST 1.1;Duration of Response (DOR) Per PCWG-modified RECIST 1.1;Overall Survival (OS);Blood Concentrations of Steroids