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Oral EPI-7386 for Prostate Cancer (EPI-7386 Trial)

Phase 1
Recruiting
Research Sponsored by ESSA Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male 18 years of age or older with histologically confirmed prostate cancer without small cell features and evidence of castration-resistant prostate cancer (CRPC)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
Must not have
Spinal cord compression
Significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, EPI-7386, for prostate cancer. The purpose is to find a dose that can be given without unacceptable side effects and to assess the drug's safety. The trial will be conducted in two parts.

Who is the study for?
Men aged 18+ with castration-resistant prostate cancer (CRPC) and metastatic disease, who have had limited treatment options and progressed on certain therapies but not more than three. They must be in good physical condition (ECOG score of 0-1), have recovered from previous treatments' side effects, and show adequate organ function. Exclusions include recent use of specific drugs, prior chemotherapy for some cohorts, allergies to drug components, other cancers within the last 3 years, significant heart conditions or uncontrolled hypertension.
What is being tested?
EPI-7386 is being tested both alone and in combination with other drugs like abiraterone acetate + prednisone (AAP) or apalutamide (APA). The study has two parts: Part A tests EPI-7386's safety at different doses; Part B tests it combined with AAP or APA. Researchers will monitor how EPI-7386 affects blood levels over time, its impact on prostate cancer and body substances, plus any potential interactions with other drugs.
What are the potential side effects?
Since this is the first human trial for EPI-7386, exact side effects are unknown. However, common side effects for similar medications may include digestive issues, fatigue, skin reactions at injection sites if applicable, changes in liver enzymes indicating liver stress which would be monitored by blood tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man over 18 with advanced prostate cancer that is resistant to hormone therapy.
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I can carry out all my daily activities without help.
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My cancer has spread to my bones or soft tissues, confirmed by scans.
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My testosterone levels are very low due to treatment or surgery.
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I have had 2-3 treatments for advanced prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have spinal cord compression.
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I have a serious heart condition.
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I have not been diagnosed with another invasive cancer in the last 3 years.
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I do not have any other major health issues.
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I have a digestive condition that affects how my body absorbs food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary efficacy variable for Part B/Cohort 1 is the incidence of protocol-defined DLT during the DLT assessment period (first 28 days of dosing); TEAEs; abnormalities in clinical laboratory parameters/vitals/ECGs; and changes in ECOG.
The primary safety variable for Part A/Phase 1a of the study is the incidence of protocol-defined DLT during the DLT assessment period (first 28 days of dosing).

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups
Experimental Treatment
Group I: Part B/Cohort 2cExperimental Treatment2 Interventions
1200 mg EPI-7386 monotherapy for 12 weeks then 1200 mg EPI-7386 + 240 mg Apalutamide
Group II: Part B/Cohort 2bExperimental Treatment2 Interventions
800 mg EPI-7386 monotherapy for 12 weeks then 800 mg EPI-7386 + 240 mg Apalutamide
Group III: Part B/Cohort 2aExperimental Treatment2 Interventions
600 mg EPI-7386 monotherapy for 12 weeks then 600 mg EPI-7386 + 240 mg Apalutamide
Group IV: Part B/Cohort 1cExperimental Treatment2 Interventions
1200 mg EPI-7386 + 1000 mg Abiraterone Acetate + Prednisone
Group V: Part B/Cohort 1bExperimental Treatment2 Interventions
800 mg EPI-7386 + 1000 mg Abiraterone Acetate + Prednisone
Group VI: Part B/Cohort 1aExperimental Treatment2 Interventions
600 mg EPI-7386 + 1000 mg Abiraterone Acetate + Prednisone
Group VII: Part A/Phase 1b: Cohort 2Experimental Treatment1 Intervention
600 mg EPI-7386 QD
Group VIII: Part A/Phase 1b: Cohort 1 (Completed)Experimental Treatment1 Intervention
600 mg EPI-7386 BID
Group IX: Part A/Phase 1a: Cohort 7 (Completed)Experimental Treatment1 Intervention
1200 mg EPI-7386
Group X: Part A/Phase 1a: Cohort 6 (Completed)Experimental Treatment1 Intervention
800 mg EPI-7386
Group XI: Part A/Phase 1a: Cohort 5 (Completed)Experimental Treatment1 Intervention
1000 mg EPI-7386
Group XII: Part A/Phase 1a: Cohort 4 (Completed)Experimental Treatment1 Intervention
800 mg EPI-7386
Group XIII: Part A/Phase 1a: Cohort 3 (Completed)Experimental Treatment1 Intervention
600 mg EPI-7386
Group XIV: Part A/Phase 1a: Cohort 2 (Completed)Experimental Treatment1 Intervention
400 mg EPI-7386
Group XV: Part A/Phase 1a: Cohort 1 (Completed)Experimental Treatment1 Intervention
200 mg EPI-7386
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone acetate
2014
Completed Phase 3
~3440
Apalutamide
2015
Completed Phase 2
~5710

Find a Location

Who is running the clinical trial?

ESSA PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
178 Total Patients Enrolled
1 Trials studying Prostate Cancer
150 Patients Enrolled for Prostate Cancer
~23 spots leftby Apr 2026
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