drugset / Trial / NCT04677855
Study of PCUR-101 in Combination With ADT in Patients With mCRPC
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with metastatic CRPC at Screening. Dose escalation uses a 3+3 design to determine the maximum tolerated dose (MTD). Once the MTD is defined, the dose expansion phase is used to define the recommended phase 2 dose.
Timeline
- Start
- 2021-03-30
- Primary completion
- 2023-10-23
- Completion
- 2023-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PLUMBAGIN | Small molecule | 50 mg | Oral |
| Background | Abiraterone acetate | Small molecule | 500 mg | — |
| Background | Dutasteride | Small molecule | 0.5 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | — |