A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 in Patients With Castration-Resistant Prostate Cancer

This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386.

Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects.

There are other important things that will be evaluated during the study:

How the amount of EPI-7386 in the blood changes over time.
The effect of EPI-7386 on prostate cancer.
The effect of EPI-7386 on certain substances in the body.
The possibility that EPI-7386 can interact with other drugs.

The study will be conducted in 2 parts:

Part A: To evaluate the safety and tolerability of EPI-7386 as a single agent via 2 Phases:

Phase 1a: Dose Escalation (mCRPC)
Phase 1b: Dose Expansion (mCRPC)

Part B: To evaluate 2 parallel enrolling cohorts (Cohort 1 and Cohort 2) of EPI-7386 in combination of apalutamide acetate + prednisone (AAP) or apalutamide (APA):

Cohort 1: Combination with AAP in mHSPC or mCRPC patients
Cohort 2: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (12 weeks EPI-7386 monotherapy prior to the start of combination therapy with APA) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

EPI-7386 (QD), EPI-7386 (BID), Abiraterone acetate, Apalutamide