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A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sponsor: GlaxoSmithKline
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
Conditions
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.