NCT05295927

A Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone, or Apalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety, including dose limiting toxicities, and the recommended phase 2 dose (RP2D) of EPI-7386 in separate combinations with (a) abiraterone acetate plus prednisone or prednisolone (AAP) and (b) apalutamide (dose-finding) and to determine the antitumor activity of EPI-7386 in separate combinations with (a) AAP and (b) apalutamide (dose-expansion).

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	EPI-7386	EPI-7386 will be administered orally once daily.
DRUG	Abiraterone Acetate	Abiraterone Acetate will be administered orally once daily.
DRUG	Prednisone or Prednisolone	Prednisone or Prednisolone will be administered orally twice daily.
DRUG	Apalutamide	Apalutamide will be administered orally once daily.

Timeline

• Start date: 2022-03-23
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2022-03-25
• Last updated: 2025-02-03

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study