RecruitingPhase 1Phase 2NCT05053971

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Phase Ib/II Study of ZEN003694 and Entinostat in Advanced and Refractory Solid Tumors

Sponsor

National Cancer Institute (NCI)

Enrollment

49 participants

Start Date

Nov 16, 2022

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Pancreatic Carcinoma Metastatic Pancreatic Carcinoma Stage II Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Refractory Malignant Solid Neoplasm Advanced Malignant Solid Neoplasm Refractory Pancreatic Carcinoma Unresectable Pancreatic Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two experimental drugs — entinostat (which helps reset gene expression in cancer cells) and ZEN003694 (which targets a protein that helps cancer cells grow) — in people with advanced solid tumors. A focused Phase 2 portion targets advanced pancreatic cancer specifically. **You may be eligible if...** - You are 18 or older with an advanced solid tumor that has not responded to standard treatments - For Phase 2: you have advanced or metastatic pancreatic cancer that has already progressed on standard therapy - You have measurable disease and are in reasonably good health (ECOG ≤2) **You may NOT be eligible if...** - You have had more than two prior chemotherapy regimens for metastatic disease - You have uncontrolled infections or significant heart problems - You are pregnant or breastfeeding - You have certain genetic conditions or prior treatments that would interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.