A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of risvutatug rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants with Metastatic Castration resistant Prostate Cancer (EMBOLD Prostate-302)

未提供0 个研究点目标入组 684 人开始时间: 待定

适应症

试验速览

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•Participants >-18 years of age
•Has histologically or cytologically confirmed adenocarcinoma of the prostate.
•Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization.
•Has a life expectancy of at least 4 months.
•Has adequate organ function

•Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
•Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
•Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix] with no evidence of metastatic disease.
•Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization,
•Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
•Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV)
•Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
•Has received systemic immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term administration [30 days or longer]).
•Has received any prior therapy with an ADC with a topoisomerase 1 inhibitor (TOPO1-inhibitor) payload

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