Testing a New Drug Combination, Entinostat and ZEN003694, for Advanced and Hard-to-Treat Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05053971

Provider View

This clinical trial is exploring a new combination of drugs, Entinostat and ZEN003694, to see if they are safe and effective in treating advanced cancers and lymphomas that have spread or are not responding to other treatments.

Patient Parameters

Program Overview

This study is testing a new combination of two drugs, Entinostat and ZEN003694, to see if they can safely and effectively treat advanced cancers and lymphomas that have spread or are not responding to other treatments. Entinostat works by blocking certain enzymes that help cancer cells grow, while ZEN003694 targets proteins that may help tumor cells grow. The trial aims to find the safest dose and understand the side effects of this combination therapy.

Description

The study is divided into two phases. In Phase I, researchers will determine the safest dose of the drug combination by observing any side effects. In Phase II, they will evaluate how well the drugs work in treating advanced pancreatic cancer.

The main goals are to find the maximum tolerated dose of the drug combination and to see how effective it is in shrinking tumors. Researchers will also look at how long patients live without the cancer getting worse and overall survival rates.

Participants will take the drugs orally, with Entinostat taken once a week and ZEN003694 taken daily. The treatment cycles repeat every 28 days unless the cancer progresses or side effects become too severe. Patients will also undergo biopsies to help researchers understand how the drugs affect the cancer.

After completing the treatment, patients will be monitored for 30 days to check for any lasting effects.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or hard-to-treat solid tumors or lymphomas.
  • For Phase II, have advanced pancreatic cancer that cannot be removed by surgery or has spread.
  • Have measurable cancer based on specific medical criteria.
  • Have tried at least one standard treatment for solid tumors or two for lymphomas.
  • Be 18 years or older.
  • Be in good overall health with a performance status score of 2 or less.
  • Have adequate blood counts and organ function based on specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after the study.
  • Be willing to undergo tumor biopsies.
  • Understand and agree to sign a consent form.
  • Have treated and stable brain metastases, if applicable.
  • Have a history of hepatitis C that is treated and cured, or currently under treatment with an undetectable viral load.

Exclusion Criteria

  • Have indolent or symptom-free lymphoma.
  • Have received any cancer treatment within 14 days before starting the study drugs.
  • Have untreated or symptomatic brain metastases.
  • Have significant digestive issues that affect oral medication.
  • Have a history of severe allergic reactions to similar drugs.
  • Be taking medications that strongly interact with the study drugs.
  • Have uncontrolled health conditions.
  • Be pregnant or breastfeeding.
  • Have certain heart conditions or recent heart issues.
  • Be using certain blood thinners.
  • Have had extensive radiation or certain treatments recently.
  • Have previously received ZEN003694 or similar drugs.

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