Risvutatug rezetecan (Ris-Rez)
BiologicalRisvutatug rezetecan (Ris-Rez) will be administered.
NCT Number: NCT07802704
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 opening soon.
Get Notified18 year and older
Male
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Risvutatug rezetecan (Ris-Rez) will be administered.
Enzalutamide will be administered.
Abiraterone will be administered.
Prednisone will be administered along with Abiraterone.
Prednisolone will be administered along with Abiraterone.
Time frame: Up to approximately 169 weeks
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.
Time frame: Up to approximately 169 weeks
OS is defined as the time from randomization to date of death by any cause.
Time frame: Up to approximately 169 weeks
Time frame: Up to approximately 169 weeks
rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.
Time frame: Up to approximately 169 weeks
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
Time frame: Up to approximately 169 weeks
DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.
Time frame: Up to approximately 169 weeks
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
Time frame: Up to approximately 169 weeks
PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.
Time frame: Up to approximately 169 weeks
Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events:
Time frame: Up to approximately 169 weeks
Time frame: Up to approximately 169 weeks
Time frame: Up to approximately 84 days
Time frame: Up to approximately 169 weeks
Time frame: Up to approximately 169 weeks
Time frame: Up to approximately 169 weeks
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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