A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer
Condition: Prostatic Neoplasms, Metastatic Castration-Resistant Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT06136598
Sponsor: Merck Sharp & Dohme LLC
Phase: Phase 1
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
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.
View trial on ClinicalTrials.gov