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Recruiting NCT07802704

A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]

Conditions: Neoplasms, Prostate

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 684
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Auchenflower Queensland

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07802704). StuddyBuddy aggregates publicly available trial information.