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.gov
NATIONAL TRIAL REFERENCE NUMBER NCT06353386
Conditions Prostatic Neoplasms, Castration-Resistant
Age Range 18+
Sex All
Current trial phase 2
Trial start and end dates [05-20-2024] [03-31-2028]
Downloads

About the trial

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

View full trial eligibility

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

In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended 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 locations (3)

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.

What can you do next?

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

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NATIONAL TRIAL REFERENCE NUMBER

NCT06353386

When you talk with your doctor or clinical trial team member, please have the national trial reference number available.

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