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

NCT06312670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-05-29

No results posted yet for this study

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.

Conditions

  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
  • Prostate Cancer
  • Prostate Adenocarcinoma

Interventions

DRUG

EPI-7386

600 mg orally administered twice daily

DRUG

Enzalutamide

160 mg administered orally once daily, with or without food

DRUG

Androgen Deprivation Therapy (ADT)

LHRH agonist/antagonist or orchiectomy

Sponsors & Collaborators

  • ESSA Pharma Inc.

    collaborator UNKNOWN

  • Pedro Barata, MD, MSc

    lead OTHER

Principal Investigators

  • Pedro Barata, MD, MSc · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  • Christopher Wee, MD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2025-01-09
Completion
2025-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312670 on ClinicalTrials.gov