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NCT05053971 · ClinicalTrials.gov registry record · Phase 1
Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors
A Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 3
- Study locations
NCT05053971: Recruiting Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT05053971 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 49 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (72% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05053971, a Phase 1 study of Advanced Malignant Solid Neoplasm and Refractory Malignant Solid Neoplasm, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
The MTD is defined as the highest dose level at which \< 33% of the dose cohort (0 of 3 or 1 of 6) experience a dose-limiting toxicity (DLT) in the first cycle. Up to 3 additional patients (maximum enrollment 6) will be added at the MTD level to more fully characterize the safety of the drug combination. If \< 33% (2) patients in this expanded cohort experience a DLT, this will be declared the MTD, and thus the phase 2 dose. If 2 or more patients experience a DLT, this dose level will be adopted
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 |
What NCT05053971 shows while recruiting
NCT05053971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (72% lower).
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.
NCT05053971 reports a single indexed study location in Connecticut, Florida, Oklahoma.
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.
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).
Who is sponsoring clinical trial NCT05053971?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05053971's enrollment target sits among peer trials
49 51st of 108 higher than 56 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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