a study of opevesostat (mk-5684) in china participants with metastatic castration-resistant prostate cancer (mcrpc) (mk-5684-001)

Conditions: Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer

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 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.