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Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
NCT05053971 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG BET Bromodomain Inhibitor ZEN-3694
- PROCEDURE Core Biopsy
- DRUG Entinostat
Study Locations (3)
Connecticut
- Yale University — New Haven
Florida
- UF Health Cancer Institute - Gainesville — Gainesville
Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2022-11-16 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05053971
The ClinicalTrials.gov registry entry for NCT05053971 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions — of which Computed Tomography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05053971 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Florida, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05053971 about?
NCT05053971 is a clinical study titled "Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors". 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 (...
What is the current status of trial NCT05053971?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2022-11-16. Estimated completion is 2026-07-01.
What conditions does trial NCT05053971 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05053971?
The interventions under investigation include: Computed Tomography (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG), Core Biopsy (PROCEDURE), Entinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05053971?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05053971 being conducted?
This trial has 3 study locations across Connecticut, Florida, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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