A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer

Merck Sharp & Dohme LLC6 sites in 1 country14 target enrollmentStarted: January 30, 2024Last updated: February 17, 2026

Conditions

Interventions

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 14
Locations: 6
Primary Endpoint: Number of Participants Who Experience an Adverse Event (AE)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 (mCRPC) and to characterize the pharmacokinetic profile of opevesostat. There are no formal hypotheses to be tested in this study.

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: Male
Accepts Healthy Volunteers: No

Inclusion 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.

Arms & Interventions

Opevesostat

Experimental

Participants will receive opevesostat by oral tablets twice daily plus dexamethasone and fludrocortisone by oral tablets once daily continuously until unacceptable toxicity or documented progression. Hydrocortisone will also be provided to participants for use as rescue medication.

Intervention: Opevesostat (Drug)

Opevesostat

Experimental

Intervention: Dexamethasone (Drug)

Opevesostat

Experimental

Intervention: Fludrocortisone (Drug)

Opevesostat

Experimental

Intervention: Hydrocortisone (Drug)

Outcomes

Primary Outcomes

Number of Participants Who Experience an Adverse Event (AE)

Time Frame: Up to approximately 20 months

An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.

Number of Participants Who Discontinue Study Intervention Due to an AE

Time Frame: Up to approximately 20 months

Maximum Plasma Concentration (Cmax) of opevesostat