EPI-7386 + Enzalutamide for Prostate Cancer

Recruiting at 23 trial locations

Overseen By Karen Villaluna

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: ESSA Pharmaceuticals

Must be taking: LHRH agonist/antagonist

Must not be taking: Biologic therapy, Chemotherapy

Disqualifiers: Seizure history, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

77 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, EPI-7386, taken by mouth along with an existing drug, enzalutamide, in patients with advanced prostate cancer that hasn't responded to standard treatments. Both drugs work together to block signals that make cancer cells grow.

Eligibility Criteria

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.

Inclusion Criteria

My prostate cancer is not responding to hormone therapy.

I am a man aged 18 or older.

I am fully active or can carry out light work.

Exclusion Criteria

I have a serious heart condition.

I am not taking medication that is sensitive to certain liver enzymes.

I have spinal cord compression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Single-arm dose escalation study of EPI-7386 in combination with a fixed dose of enzalutamide to evaluate safety and tolerability and establish RP2CDs

4 weeks

Multiple visits for dose escalation and monitoring

Phase 2 Treatment

Two-arm, randomized (2:1), open-label study comparing EPI-7386 + enzalutamide vs. enzalutamide alone

Until disease progression or unacceptable toxicity

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enzalutamide
• EPI-7386

Trial Overview 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.

Participant Groups

Group I: Phase 2 Enzalutamide + EPI-7386 (Randomized 2:1) Experimental Treatment 1 Intervention

RP2D mg EPI-7386 in combination of Enzalutamide RP2D mg

Group II: Phase 1 Cohort 4 Experimental Treatment 1 Intervention

RP2D mg EPI-7386 in combination of Enzalutamide160 mg

Group III: Phase 1 Cohort 3 Experimental Treatment 1 Intervention

600 mg BID EPI-7386 in combination of Enzalutamide120 mg

Group IV: Phase 1 Cohort 2 Experimental Treatment 1 Intervention

800 mg QD EPI-7386 in combination of Enzalutamide120 mg

Group V: Phase 1 Cohort 1 Experimental Treatment 1 Intervention

600 mg QD EPI-7386 in combination of Enzalutamide120 mg

Group VI: Phase 2 Enzalutamide single agent Active Control 1 Intervention

Enzalutamide 160 mg

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in European Union as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Canada as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Japan as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Who Is Running the Clinical Trial?

ESSA Pharmaceuticals

Lead Sponsor

Trials

3

Recruited

180+