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NOT YET RECRUITING
NCT07802704
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

684

Start Date

2026-09-22

Completion Date

2029-12-19

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Risvutatug rezetecan (Ris-Rez)

Risvutatug rezetecan (Ris-Rez) will be administered.

DRUG

Enzalutamide

Enzalutamide will be administered.

DRUG

Abiraterone

Abiraterone will be administered.

DRUG

Prednisone

Prednisone will be administered along with Abiraterone.

DRUG

Prednisolone

Prednisolone will be administered along with Abiraterone.