Recruiting
Phase 3

Risvutatug Rezetecan vs. BSC

Sponsor:

GlaxoSmithKline

Code:

NCT07802704

Conditions

Neoplasms, Prostate

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Risvutatug rezetecan (Ris-Rez)

Enzalutamide

Abiraterone

Prednisone

Prednisolone

Study Details

Brief 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.

Conditions

Neoplasms, Prostate

Study ID

NCT07802704

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 5, 2029

Anticipated

Primary completion date

Dec 5, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

684 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Risvutatug rezetecan (Ris-Rez)

Participants will receive Risvutatug rezetecan (Ris-Rez).

active comparator: Standard of Care

Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).

Interventions

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.

Primary outcome measure

  • Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR [ Time Frame: Up to approximately 169 weeks ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 169 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Montreal, Quebec, Canada, H4A 0B1

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramy Saleh

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Metastatic Castration-resistant Prostate Cancer
  • Risvutatug rezetecan
  • Ris-Rez
  • GSK5764227
  • Enzalutamide
  • Abiraterone
  • Antibody-Drug Conjugate
  • EMBOLD Prostate-302

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.