drugset / Trial / NCT06353386
Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2024-05-20
- Primary completion
- 2029-01-15
- Completion
- 2029-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Opevesostat | Small molecule | 5 mg | Oral |
| Background | Dexamethasone | Small molecule | 1.5 mg | Oral |
| Background | Fludrocortisone | Other / unclassified | 0.1 mg | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |