Clinical Trial

Randomized Phase 2b Study of ZEN003694 in Combination with Enzalutamide versus Enzalutamide Monotherapy in Patients with Metastatic Castration-Resistant Prostate Cancer (ZEN003694-201)

MOA: ZEN003694 epigenetically regulates gene expression through bromodomain and extra-terminal domain (BET) inhibition.

Key Eligibility Criteria:

• Metastatic, castration-resistant, histologically confirmed prostate cancer that has progressed on prior abiraterone treatment
• Patient must meet definition of poor responder to abiraterone by one of the following:
  • Cohort A: In HSPC setting, <12 months on abiraterone or failure to achieve PSA nadir of 0.2 ng/mL; In CRPC setting, <6 months on abiraterone or failure to achieve a PSA50 response
  • Cohort B: In HSPC setting, ≥12 months duration on abiraterone and nadir PSA ≤ 0.2 ng/mL; In CRPC setting, ≥6 months duration on abiraterone and PSA50 response
• Subjects whose disease is not aggressive or progressing rapidly enough to prefer chemotherapy over second-line ARSI, as per investigator’s opinion
• Subjects that have received second-generation androgen receptor inhibitors are excluded
• Subjects that have received prior chemotherapy in the metastatic castration-resistant setting are excluded