MK-5684-01A
Substudy 01A: Safety and Efficacy of Opevesostat -Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer
Recruiting
Trial purpose
Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).
The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.
This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
View full trial information on Clinicaltrials.govNATIONAL TRIAL REFERENCE NUMBER
NCT06353386
When you talk with your doctor or clinical trial team member, please have the national trial reference number available.
Eligibility
Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.
Conditions
Prostatic Neoplasms, Castration-Resistant
Age Range
18+
Sex
Male/Female
About the trial
Current trial Phase
Phase 1
Investigational medication is tested for safety on a relatively small group of 20 to 100 volunteers who are usually healthy, but not always. Phase 1 trials may happen in a doctor’s office or a hospital.
Phase 2
Tests the medicine or vaccine in approximately 100 to 500 participants. In the case of medicines, participants usually have the disease or condition the investigational medicine is designed to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.
Trial start and end dates
- Trial start date 05-20-2024
- Estimated primary completion date 01-15-2029
- Estimated trial completion date 01-15-2029
Trial Locations
Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.