N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: GlaxoSmithKline • ClinicalTrials.gov ID: NCT07802704

Registry updated: 2026-10-02
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Risvutatug rezetecan (Ris-Rez) (Biological)
    Risvutatug rezetecan (Ris-Rez) will be administered.
  • Enzalutamide (Drug)
    Enzalutamide will be administered.
  • Abiraterone (Drug)
    Abiraterone will be administered.
  • Prednisone (Drug)
    Prednisone will be administered along with Abiraterone.
  • Prednisolone (Drug)
    Prednisolone will be administered along with Abiraterone.

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

Conditions

Neoplasms, Prostate

Locations

  • GSK Investigational Site — Auchenflower, Queensland, Australia
  • GSK Investigational Site — Montreal, Quebec, Canada
  • GSK Investigational Site — Tokyo, Japan
  • GSK Investigational Site — Tottori, Japan
  • GSK Investigational Site — Seoul, Seoul Teugbyeolsi, South Korea
  • GSK Investigational Site — Gyeonggi-do, South Korea
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record