Combination of ZEN003694 and Enzalutamide for Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2b clinical trial evaluates the effectiveness of ZEN003694 in combination with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously progressed on abiraterone. Participants are divided into two cohorts based on their response to prior abiraterone treatment, with specific criteria defining poor responders and those with a better response. The study aims to determine if the combination therapy can improve outcomes for patients who have not responded well to previous treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males age ≥ 18 years
2. Metastatic, castration-resistant, histologically confirmed prostate cancer
3. Surgical castration or continuous medical castration for ≥ 8 weeks prior to screening; serum testosterone \< 50 ng/dL confirmed within 4 weeks of first administration of study drug
4. Have progressed on prior abiraterone treatment by PCWG3 criteria
5. Patients who are not candidates for chemotherapy in the opinion of the investigator or patients who decline chemotherapy
6. Cohort A only - Patient must meet definition of poor responder to abiraterone by one of the following:

   1. Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: \< 12 months duration on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL while taking abiraterone
   2. Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: \< 6 months duration on abiraterone or failure to achieve a PSA50 response
7. Cohort B only - Patient must meet definition of responder to abiraterone by one of the following:

   1. Abiraterone started in hormone-sensitive prostate cancer (HSPC) disease setting: ≥ 12 months duration on abiraterone and nadir PSA \< 0.2 ng/mL
   2. Abiraterone started in castrate-resistant prostate cancer (CRPC) disease setting: ≥ 6 months duration on abiraterone and PSA50 response
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

1. Any history of brain metastases, prior seizure, conditions predisposing to seizure activity
2. Have previously received an investigational BET inhibitor (including previous participation in this study or a study of ZEN003694)
3. Receipt of prior second-generation androgen receptor inhibitors (e.g. enzalutamide, apalutamide, darolutamide, proxalutamide). Receipt of first-generation AR antagonists (e.g. bicalutamide, nilutamide, flutamide) does not count towards this limit.
4. Have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to first dose of study drug)
5. Have received prior systemic anti-cancer therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug
6. Have received exogenous administration of testosterone therapy since discontinuation of abiraterone.
7. Failure to recover to Grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry
8. Radiation therapy within 2 weeks of the first administration of study drug

Where it's running

• California Research Institute
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Innovative Clinical Research Institute
  Whittier, California, United States Recruiting
• Colorado Urology
  Lakewood, Colorado, United States Recruiting
• D&H Cancer Research Center, LLC
  Margate, Florida, United States Recruiting
• BRCR Global
  Plantation, Florida, United States Recruiting

Study contacts

• Study coordinator: Zenith Study Team
• Email: ZEN003694-201@zenithepigenetics.com
• Phone: 587-390-7865

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.