Study Type: Interventional (Clinical Trial)

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