Actively Recruiting
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-04-13
49
Participants Needed
3
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have advanced or refractory solid tumor and meet standard treatment requirements
- For Phase 2, patients must have locally advanced, unresectable or metastatic pancreatic cancer refractory to standard therapy
- Patients with solid tumors must have measurable disease based on RECIST 1.1 criteria
- Patients with solid tumors must have received at least one standard of care regimen for metastatic disease
- Age 18 years or older
- ECOG performance status 1 or lower (Karnofsky 70% or higher)
- Hemoglobin 9.0 g/dL or higher (within 14 days before treatment)
- Absolute neutrophil count 1,500/mcL or higher (within 14 days before treatment)
- Platelets 100,000/mcL or higher (within 14 days before treatment)
- Total bilirubin 1.5 times or less the institutional upper limit of normal (within 14 days before treatment)
- AST and ALT 2.5 times or less the institutional upper limit of normal (within 14 days before treatment)
- Glomerular filtration rate 60 mL/min/1.73 m2 or higher if creatinine above normal (within 14 days before treatment)
- Prothrombin time/INR and partial thromboplastin time less than 1.5 times upper limit of normal (within 14 days before treatment)
- Albumin greater than 2.5 g/dL (within 14 days before treatment)
- Patients with treated brain metastases are eligible if follow-up imaging 4 weeks after CNS therapy shows no progression
- Patients with prior or concurrent malignancy not interfering with study safety or efficacy
- New York Heart Association Functional Classification class 2B or better
- Able to swallow and retain oral medication
- Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment
- Women of childbearing potential and their male partners must agree to use contraception during the study and for 3 months after treatment
- Ability to understand and sign informed consent or have a legally authorized representative
- Patients with history of hepatitis C infection must be treated and cured or have undetectable viral load if currently treated
You will not qualify if you...
- Any anti-cancer therapy within 30 days or 5 half-lives before first dose
- Radiation therapy within 21 days before first dose
- Diagnosis of NK cell lymphoma
- Not recovered from prior anti-cancer therapy side effects above grade 1 except alopecia or stable chronic grade 2 not overlapping with study drug toxicities
- Receiving other investigational agents
- Untreated or symptomatic brain or leptomeningeal metastases; stable CNS disease allowed if stable for at least 4 weeks without symptoms and off corticosteroids
- Significant malabsorption or nausea/vomiting interfering with oral therapy
- Bleeding disorders or significant bleeding within prior 6 months
- Allergic reactions to similar compounds to entinostat or ZEN003694
- Use of medications that strongly affect CYP3A4 or CYP1A2 enzymes unless discontinued 7 days prior
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding women
- Cardiac issues including QTcF >450 msec, use of QTc prolonging agents, significant arrhythmias, pacemaker limiting ECG analysis, NYHA class II or higher heart failure, recent acute coronary syndrome or stenting, cardiomegaly, hypertrophy, or cardiomyopathy
- Use of oral Factor Xa or Factor IIa inhibitors (except low molecular weight heparin)
- Radiation to more than 25% of bone marrow
- Bone-targeted radionuclide therapy within 6 weeks before first dose
- Previous treatment with ZEN003694, HDAC inhibitor, or investigational BET inhibitor
- Major surgery within 4 weeks before first dose except diagnostic, dental, or stenting surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
3
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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