Phase III Study of Entinostat and ZEN003694 for Treatment of Advanced and Refractory Solid Tumors including Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of a combination treatment using entinostat and ZEN003694 for patients with advanced or refractory solid tumors, including pancreatic cancer. Entinostat is a histone deacetylase inhibitor that may stop tumor growth by blocking enzymes needed for cell growth, while ZEN003694 is a bromodomain and extra-terminal BET protein inhibitor that may prevent tumor growth by targeting BET protein overproduction. This phase III trial aims to find the maximum tolerated dose and assess the overall response rate in pancreatic cancer patients. Participants receive oral doses of entinostat and ZEN003694 in repeated 28-day cycles unless disease progression or unacceptable toxicity occurs. The current dosing schedule involves entinostat given once weekly on days 1, 8, 15, and 22, and ZEN003694 given orally on specific days within each cycle days 1-5, 8-12, 15-19, and 22-26. Patients undergo computed tomography scans throughout the study to monitor tumor status. Earlier dosing schedules and biopsy procedures are no longer used as of an amendment dated June 12, 2025. During the study, participants undergo regular assessments including CT scans and blood tests to monitor safety and response. The research team measures maximum tolerated dose, recommended phase 2 dose, objective response rates, and survival outcomes. Patients are followed for 30 days after completing treatment to observe safety and any lasting effects, ensuring close monitoring throughout their participation, which lasts as long as treatment continues or until progression or toxicity occurs.

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