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:

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