LAEKNA
Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Intervention Model Description: Phase 1 Dose Escalation to determine Recommended Phase II Dose (RP2D) of LAE001/Prednisone plus Afuresertib in m-CRPC patients. Once RP2D is determined, Phase II will evaluate LAE001/Prednisone plus Afuresertib vs Afuresertib monotherapy in m-CRPC patients.
- Estimated Enrollment: 74 participants
- Masking: None (Open Label)
- Primary Purpose: Treatment
Official Title: A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment