NCT07802704

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for phase_3

Timeline
39mo left

Started Sep 2026

Typical duration for phase_3

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Dec 2029

First Submitted

Initial submission to the registry

August 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2029

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

3.3 years

First QC Date

August 28, 2026

Last Update Submit

October 1, 2026

Conditions

Neoplasms, Prostate

Keywords

Metastatic Castration-resistant Prostate CancerRisvutatug rezetecanRis-RezGSK5764227EnzalutamideAbirateroneAntibody-Drug ConjugateEMBOLD Prostate-302

Outcome Measures

Primary Outcomes (2)

  • Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR

    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.

    Up to approximately 169 weeks

  • Overall Survival (OS)

    OS is defined as the time from randomization to date of death by any cause.

    Up to approximately 169 weeks

Secondary Outcomes (13)

  • Time to Pain Progression (TTPP)

    Up to approximately 169 weeks

  • rPFS by Investigator assessment

    Up to approximately 169 weeks

  • Confirmed Objective Response Rate (cORR)

    Up to approximately 169 weeks

  • Duration of Response (DoR)

    Up to approximately 169 weeks

  • Time to Prostate-specific antigen (PSA) progression

    Up to approximately 169 weeks

  • +8 more secondary outcomes

Study Arms (2)

Risvutatug rezetecan (Ris-Rez)

EXPERIMENTAL

Participants will receive Risvutatug rezetecan (Ris-Rez).

Biological: Risvutatug rezetecan (Ris-Rez)

Standard of Care

ACTIVE COMPARATOR

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).

Drug: EnzalutamideDrug: AbirateroneDrug: PrednisoneDrug: Prednisolone

Interventions

EnzalutamideDRUG

Enzalutamide will be administered.

Standard of Care
AbirateroneDRUG

Abiraterone will be administered.

Standard of Care
PrednisoneDRUG

Prednisone will be administered along with Abiraterone.

Standard of Care
PrednisoloneDRUG

Prednisolone will be administered along with Abiraterone.

Standard of Care
Risvutatug rezetecan (Ris-Rez)BIOLOGICAL

Risvutatug rezetecan (Ris-Rez) will be administered.

Risvutatug rezetecan (Ris-Rez)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

GSK Investigational Site

Auchenflower, Queensland, 4066, Australia

RECRUITING

GSK Investigational Site

Montreal, Quebec, H4A 0B1, Canada

RECRUITING

GSK Investigational Site

Tokyo, 135-8550, Japan

RECRUITING

GSK Investigational Site

Tottori, 683-8504, Japan

RECRUITING

GSK Investigational Site

Seoul, Seoul Teugbyeolsi, 3080, South Korea

RECRUITING

GSK Investigational Site

Gyeonggi-do, 10408, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamideabirateronePrednisonePrednisolone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriols

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 3, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

December 5, 2029

Study Completion (Estimated)

December 5, 2029

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
More information

Locations

AU(1)CA(1)KR(2)JP(2)