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

COMPLETEDPHASE1

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

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

NCT06136598•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.
+4 more criteria

Locations (3)

Peking University First Hospital-Urology ( Site 0001)

Beijing, Beijing Municipality, China

Sun Yat-sen University Cancer Center-Neurosurgery department ( Site 0003)

Guangzhou, Guangdong, China

Tongji Hospital Tongji Medical,Science & Technology ( Site 0002)

Wuhan, Hubei, China

Key Dates

Start Date

January 30, 2024

Primary Completion Date

March 9, 2026

Completion Date

March 9, 2026

Last Updated

March 19, 2026

Enrollment

ACTUAL participants

Conditions

Prostatic NeoplasmsMetastatic Castration-Resistant Prostate Cancer

Interventions

Opevesostat

DRUG

Dexamethasone

DRUG

Fludrocortisone

DRUG

Hydrocortisone

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

NCT05489211

Endometrial CancerGastric Cancer+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC