Clinical trialNCT06312670CompletedPhase 2Interventional

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

SponsorPedro Barata, MD, MScEnrollment13Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Prostate AdenocarcinomaProstate Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Christopher Wee, MD
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Principal Investigator
clinicaltrials.gov ↗
Pedro Barata, MD, MSc
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Androgen Deprivation Therapy →EPI-7386Enzalutamide →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 16 May 2024
Primary completion: 9 Jan 2025
Completion: 9 Jan 2025
Last update posted: 29 May 2025
Registered enrollment: 13
Registry id: NCT06312670

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.