Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

Summary

The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.

Timeline

Start

2024-05-16

Primary completion

2025-01-09

Completion

2025-01-09

Publications

• Jang A, Fowler P, Helminiak K, Kumar HLS, Pasucal J, Delong V, Zhong JY, Jindal T, Grier AL, Patel RR, Hislop M, Cesano A, Villaluna K, Younginger B, Wolff K, Richey K, Bray J, Garcia H, Adamowicz T, Reese A, Nizam A, Gupta S, Wee CE, Margevicius S, Fu P, Mendiratta P, Sheng IY, Brown JR, Garcia JA, Barata PC. EXTRA-PC: a phase II trial of masofaniten (EPI-7386) and enzalutamide for patients with treatment-naive metastatic hormone-sensitive prostate cancer. Oncologist. 2026 Jan 17;31(2):oyaf434. doi: 10.1093/oncolo/oyaf434.

Drugs

Indications