drugset / Trial / NCT06190899
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2028-01
- Completion
- 2030-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gedatolisib | Small molecule | 120 mg | — |
| Subject | Gedatolisib | Small molecule | 180 mg | — |
| Background | Darolutamide | Other / unclassified | 600 mg | Oral |