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BET Bromodomain Inhibitor ZEN-3694 / Refractory Malignant Solid Neoplasm / Advanced Malignant Solid Neoplasm · Phase 1 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 1 combination trial of a BET inhibitor (ZEN003694) and a MEK inhibitor (binimetinib) in patients with RAS-altered solid tumors and triple-negative breast cancer. The trial is actively recruiting and designed to assess safety and define a tolerable dose; no efficacy or safety results are yet reported in this registry record.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Triple-Negative Breast Carcinoma, Unresectable Mal…; age from 18 Years. Intervention: Treatment (ZEN-3694, binimetinib). n = 42. 4 sites: United States.
This is a planned Phase 1 combination trial of a BET inhibitor (ZEN003694) and a MEK inhibitor (binimetinib) in patients with RAS-altered solid tumors and triple-negative breast cancer. The trial is actively recruiting and designed to assess safety and define a tolerable dose; no efficacy or safety results are yet reported in this registry record.
No data on response rates, survival, or tolerability at specific doses are available.
The source did not state who this applies to in practice.
This is a Phase 1 trial registration with no results posted; it describes planned enrollment and safety endpoints only, without outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05111561). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 42 participants (ESTIMATED). Conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Triple-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm. Interventions: DRUG: BET Bromodomain Inhibitor ZEN-3694; DRUG: Binimetinib; PROCEDURE: Biopsy Procedure; PROCEDURE: Biospecimen Collection; PROCEDURE: Computed Tomography; PROCEDURE: Magnetic Resonance Imaging. Primary outcome measures: Incidence of dose limiting toxicities (Part 1 [Dose Escalation]) , Up to 28 days from treatment start date; Incidence of AEs (Part 2 [Dose Expansion]) , Up to 30 days after last treatment dose. Brief summary: This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with binimetinib in treating patients with solid tumors that carry RAS alterations and that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an oral medication with potential anticancer activity. It is an inhibitor of a family of proteins called bromodomain and extra-terminal (BET) which play important role during development and cellular growth. ZEN003694 may stop the growth of tumor cells that produce BET. Binimetinib is in a class of medications called kinase inhibitors. It works by blocking the action proteins called MEK1 and MEK2, that signal cancer cells to multiply. It may help keep cancer cells from growing and spreading. There is pre-clinical evidence that using ZEN003694 and binimetinib together may shrink or stabilize cancers studied in this trial. There are two parts of this study; dose escalation and dose expansion. In the dose escalation part of this study, different people will get different doses of the study drugs ZEN003694 and binimetinib. In the dose expansion part of this study, the highest dose with manageable side effects will be given to additional people. This will help to understand the side effects that may happen with this drug combination.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.