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A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]
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
2026-09-01
Completion Date
2029-12-05
Last Updated
2026-10-02
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.
Locations (6)
GSK Investigational Site
Auchenflower, Queensland, Australia
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tottori, Japan
GSK Investigational Site
Seoul, Seoul Teugbyeolsi, South Korea
GSK Investigational Site
Gyeonggi-do, South Korea