71 Participants Needed

Oral EPI-7386 for Prostate Cancer

(EPI-7386 Trial)

Recruiting at 10 trial locations
KV
Overseen ByKaren Villaluna
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: ESSA Pharmaceuticals
Must be taking: Apalutamide, Prednisone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a phase I, clinical research study of EPI-7386, an investigational drug being studied as a treatment for patients with prostate cancer. All patients in the study will receive EPI-7386. Since this is the first study of EPI-7386 in humans, there is no information about how it affects people or what dose should be used. Therefore, the main purpose of this study is to assess the safety (side effects) of EPI-7386 and to find a dose that can be given without unacceptable side effects. There are other important things that will be evaluated during the study: * How the amount of EPI-7386 in the blood changes over time. * The effect of EPI-7386 on prostate cancer. * The effect of EPI-7386 on certain substances in the body. * The possibility that EPI-7386 can interact with other drugs. The study will be conducted in 2 parts: * Part A: To evaluate the safety and tolerability of EPI-7386 as a single agent via 2 Phases: * Phase 1a: Dose Escalation (mCRPC) * Phase 1b: Dose Expansion (mCRPC) * Part B: To evaluate 2 parallel enrolling cohorts (Cohort 1 and Cohort 2) of EPI-7386 in combination of apalutamide acetate + prednisone (AAP) or apalutamide (APA): * Cohort 1: Combination with AAP in mHSPC or mCRPC patients * Cohort 2: Will evaluate the anti-tumor activity of EPI-7386 for a limited window of time (12 weeks EPI-7386 monotherapy prior to the start of combination therapy with APA) in nmCRPC patients unperturbed by previous 2nd generation anti-androgen therapies or chemotheraphy.

Eligibility Criteria

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.

Inclusion Criteria

I am eligible for AAP treatment as per standard care.
I am a man over 18 with advanced prostate cancer that is resistant to hormone therapy.
I can carry out all my daily activities without help.
See 9 more

Exclusion Criteria

I have received a blood transfusion in the last 28 days.
I have spinal cord compression.
I haven't taken strong CYP3A inducers in the last 14 days.
See 10 more

Treatment Details

Interventions

  • EPI-7386
Trial OverviewEPI-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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

ESSA Pharmaceuticals

Lead Sponsor

Trials
3
Recruited
180+