← Back to Search

Androgen Receptor Antagonist

EPI-7386 + Enzalutamide for Prostate Cancer

Phase 1 & 2
Recruiting
Research Sponsored by ESSA Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of castration-resistant prostate cancer (CRPC)
Males ≥18 years
Must not have
Significant cardiovascular disease
Use of narrow therapeutic index sensitive CYP2C8 or sensitive substrates for CYP3A and CYP2B6
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of cycle 1 (each cycle is 28 days)
Awards & highlights

Summary

This trial is testing a new combination drug to see if it is safe and effective in treating prostate cancer that has spread.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, who haven't used second-generation anti-androgens or certain other treatments recently. They must have good performance status (able to carry out daily activities) and organ function, with low testosterone levels maintained by ongoing treatment.Check my eligibility
What is being tested?
The trial is testing a new drug combo for advanced prostate cancer. Phase 1 checks the safety of EPI-7386 with enzalutamide at different doses. Phase 2 compares two groups: one taking both drugs and another taking only enzalutamide, based on earlier results for effectiveness without worsening disease.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer medications such as fatigue, digestive issues, skin reactions, potential blood disorders, hormonal changes affecting mood or energy levels, and possibly seizures due to the nature of these drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer is not responding to hormone therapy.
Select...
I am a man aged 18 or older.
Select...
I am fully active or can carry out light work.
Select...
I have not taken second generation anti-androgens.
Select...
My cancer has spread to my bones or other parts of my body, confirmed by scans.
Select...
My prostate cancer has been confirmed by a lab test.
Select...
I am on hormone therapy for cancer or have had surgery to remove my testicles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious heart condition.
Select...
I am not taking medication that is sensitive to certain liver enzymes.
Select...
I have spinal cord compression.
Select...
I cannot be treated with enzalutamide.
Select...
I have a rare hereditary fructose intolerance.
Select...
My brain metastasis has been treated and stable for at least 28 days.
Select...
I am not taking medications that strongly affect liver enzyme CYP2C8.
Select...
I am allergic to ingredients in EPI-7386 or enzalutamide.
Select...
I am not taking medication that strongly affects liver enzymes.
Select...
I haven't used hormonal agents for prostate cancer in the last 28 days.
Select...
I had targeted bone radiotherapy or any radiotherapy within the last 2 weeks.
Select...
I have stomach or intestine problems that affect how my body absorbs medicine.
Select...
I haven't used any immune system boosters in the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of cycle 1 (each cycle is 28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of cycle 1 (each cycle is 28 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Changes in ECOG performance status
Phase 1: Incidence of Dose Limiting Toxicities
Phase 1: Incidence of laboratory abnormalities as a measure of safety and tolerability of EPI-7386
+2 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1)Experimental Treatment1 Intervention
RP2D mg EPI-7386 in combination of Enzalutamide RP2D mg
Group II: Phase 1 Cohort 4Experimental Treatment1 Intervention
RP2D mg EPI-7386 in combination of Enzalutamide160 mg
Group III: Phase 1 Cohort 3Experimental Treatment1 Intervention
600 mg BID EPI-7386 in combination of Enzalutamide120 mg
Group IV: Phase 1 Cohort 2Experimental Treatment1 Intervention
800 mg QD EPI-7386 in combination of Enzalutamide120 mg
Group V: Phase 1 Cohort 1Experimental Treatment1 Intervention
600 mg QD EPI-7386 in combination of Enzalutamide120 mg
Group VI: Phase 2 Enzalutamide single agentActive Control1 Intervention
Enzalutamide 160 mg

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments often target the androgen receptor (AR) pathway, which is crucial for the growth and survival of prostate cancer cells. Androgen receptor antagonists, like EPI-7386, block the binding of androgens (male hormones) to the AR, preventing the activation of the receptor. Androgen receptor inhibitors, such as enzalutamide, not only block androgen binding but also inhibit the AR's nuclear translocation and its interaction with DNA, further disrupting cancer cell growth. These mechanisms are vital for prostate cancer patients because they effectively reduce the cancer's ability to use androgens for growth, thereby slowing disease progression and improving survival outcomes.
Overall survival and adverse events after treatment with darolutamide vs. apalutamide vs. enzalutamide for high-risk non-metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis.Androgen Deprivation Therapy and Secondary Hormone Therapy in the Management of Hormone-sensitive and Castration-resistant Prostate Cancer.

Find a Location

Who is running the clinical trial?

ESSA PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
127 Total Patients Enrolled
1 Trials studying Prostate Cancer
99 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Androgen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05075577 — Phase 1 & 2
Prostate Cancer Research Study Groups: Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1), Phase 2 Enzalutamide single agent, Phase 1 Cohort 2, Phase 1 Cohort 1, Phase 1 Cohort 4, Phase 1 Cohort 3
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT05075577 — Phase 1 & 2
Enzalutamide (Androgen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075577 — Phase 1 & 2
~42 spots leftby Aug 2025