OncoMatch/Clinical Trials/NCT05053971
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
Is NCT05053971 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including BET Bromodomain Inhibitor ZEN-3694 and Entinostat for advanced malignant solid neoplasm.
Treatment: BET Bromodomain Inhibitor ZEN-3694 · Entinostat — This phase I/II trial tests the safety, side effects, and best dose of entinostat and ZEN003694 in treating patients with solid tumors that have spread to other places in the body (advanced) or does not respond to treatment (refractory). Entinostat is in a class of drugs called histone deacetylase (HDAC) inhibitors. It may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. This trial aims to test the safety of combination therapy with entinostat and ZEN003694 in treating patients with advanced or refractory solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Pancreatic Cancer
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard of care regimen for metastatic disease — metastatic
must have received at least one standard of care regimen for metastatic disease
Cannot have received: anti-cancer therapy
Patients who have had any anti-cancer therapy within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational products
Cannot have received: radiation therapy
Patients who have received radiation therapy within 21 days prior to the first dose of the investigational products
Cannot have received: bone-targeted radionuclide
Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694
Cannot have received: HDAC inhibitor
Patients who have been treated with an HDAC inhibitor
Cannot have received: investigational BET inhibitor
Patients who have been treated with an investigational BET inhibitor
Cannot have received: ZEN003694 (ZEN003694)
Patients who have previously received ZEN003694
Lab requirements
Blood counts
Hemoglobin >= 9.0 g/dL; ANC >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
GFR >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN
Cardiac function
NYHA class 2B or better; QTcF <= 450 msec; no clinically significant conduction abnormalities or arrhythmias; no history or evidence of >= Class II congestive heart failure; no recent acute coronary syndromes, angioplasty, or stenting within 6 months; no clinically significant cardiomegaly, ventricular hypertrophy, or cardiomyopathy
Hemoglobin >= 9.0 g/dL... ANC >= 1,500/mcL... Platelets >= 100,000/mcL... Total bilirubin <= 1.5 x institutional ULN... AST/ALT <= 2.5 x institutional ULN... GFR >= 60 mL/min/1.73 m^2... PT/INR and PTT < 1.5 x ULN... Albumin > 2.5 g/dL... NYHA class 2B or better... QTcF <= 450 msec... no clinically significant conduction abnormalities or arrhythmias... no history or evidence of >= Class II congestive heart failure... no recent acute coronary syndromes, angioplasty, or stenting within 6 months... no clinically significant cardiomegaly, ventricular hypertrophy, or cardiomyopathy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
- UF Health Cancer Institute - Gainesville · Gainesville, Florida
- University of Oklahoma Health Sciences Center · Oklahoma City, Oklahoma
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