Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BET Bromodomain Inhibitor ZEN-3694 · 1 trial · 6 indications
Defined as either objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (complete response (CR), partial response (PR)) or confirmed \>= 50% decline from serum prostate-specific antigen (PSA) at baseline confirmed by repeat measurement performed ≥ 4 weeks later for each study cohort. To be considered evaluable for PSA50 response, patients must have a serum PSA \>=2 ng/mL at baseline. To be considered evaluable for objective response, patients must have measurable soft tissue disease by RECIST 1.1 criteria on baseline scan assessment. The composite response rate along with 95% confidence interval will be reported for participants in each study cohort.
| Arm | Type | Description |
|---|---|---|
| Safety Cohort | EXPERIMENTAL | Patients receive 96mg pembrolizumab IV over 30 minutes on day 1, BET bromodomain inhibitor ZEN-3694 PO QD and enzalutamide PO QD on days 1-21. Patients not on enzalutamide prior to study enrollment or have previously discontinued enzalutamide receive BET bromodomain inhibitor ZEN-3694 beginning on day 1 of cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort A: Transdifferentiated mCRPC | EXPERIMENTAL | Patients receive pembrolizumab IV over 30 minutes on day 1, BET bromodomain inhibitor ZEN-3694 PO QD and enzalutamide PO QD on days 1-21. Patients not on enzalutamide prior to study enrollment or have previously discontinued enzalutamide receive BET bromodomain inhibitor ZEN-3694 beginning on day 1 of cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Cohort B: mCRPC without evidence of transdifferentiation | EXPERIMENTAL | Patients receive pembrolizumab IV over 30 minutes on day 1, BET bromodomain inhibitor ZEN-3694 PO QD and enzalutamide PO QD on days 1-21. Patients not on enzalutamide prior to study enrollment or have previously discontinued enzalutamide receive BET bromodomain inhibitor ZEN-3694 beginning on day 1 of cycle 2. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| BET Bromodomain Inhibitor ZEN-3694 | DRUG | Given PO |
| Enzalutamide | DRUG | Given PO |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: 1. Participants must have histologically confirmed prostate adenocarcinoma at the time of diagnosis, with subsequent development of metastatic castration-resistant prostate cancer. Patients with de novo small cell prostate cancer at the time of diagnosis are excluded from study ...
ZEN-3694 is a BET bromodomain inhibitor being developed for the treatment of castration-resistant prostate carcinoma. It is currently in Phase 2 clinical development as an investigational therapy for this oncology indication.
ZEN-3694 is a small molecule that inhibits BET bromodomain proteins. By targeting these proteins, it is designed to modulate gene expression involved in cancer cell growth and survival, which is relevant to its use in castration-resistant prostate cancer.
ZEN-3694 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with castration-resistant prostate cancer.
ZEN-3694 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants.
ZEN-3694 is being studied in clinical trial NCT04471974, titled 'ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer.' This Phase 2 trial has an enrollment of 61 participants and is being conducted in the United States.
ZEN-3694 is a BET bromodomain inhibitor and is not known to be the same as other drugs. It is being studied in combination with enzalutamide and pembrolizumab in the treatment of metastatic castration-resistant prostate cancer.