A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

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)

This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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