drugset / Trial / NCT05191017
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Non-randomizedSequentialOpen-labelTreatment
Summary
NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Timeline
- Start
- 2022-09
- Primary completion
- 2025-01
- Completion
- 2026-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NUV-422 | Unknown | — | Oral |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |