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


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Exclusion Criteria:

  1. 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