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Recruiting Phase 3

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

NCT07802704 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2026-09-01
Last updated
2026-10-02

Condition(s) studied

Neoplasms, Prostate

Investigational drug(s) / intervention(s)

Risvutatug rezetecan (Ris-Rez) →Enzalutamide →Abiraterone →Prednisone →Prednisolone →

Risvutatug rezetecan (Ris-Rez): Risvutatug rezetecan (Ris-Rez) will be administered.

Enzalutamide: Enzalutamide will be administered.

Abiraterone: Abiraterone will be administered.

Prednisone: Prednisone will be administered along with Abiraterone.

Prednisolone: Prednisolone will be administered along with Abiraterone.

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR — Up to approximately 169 weeks
    rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
  • Overall Survival (OS) — Up to approximately 169 weeks
    OS is defined as the time from randomization to date of death by any cause.

Trial sites (6)

FacilityCityRegionStatus
GSK Investigational Site Auchenflower Queensland Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Tokyo Japan Recruiting
GSK Investigational Site Tottori Japan Recruiting
GSK Investigational Site Seoul Seoul Teugbyeolsi Recruiting
GSK Investigational Site Gyeonggi-do South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07802704 on ClinicalTrials.gov ↗ ← All trials in Canada