Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers (NCT05803382)
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. 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. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (16 items).
Location: UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Previous treatment with BET inhibitors
- History of inability to tolerate capecitabine at the projected treatment dose on this trial
- Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
- Treatment for HIV, hepatitis B or hepatitis C only if this interferes with the current treatment (e.g. through drug-drug interactions)
- Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication
- Hepatic tumor burden \> 30% or peritoneal carcinomatosis
- Untreated/uncontrolled central nervous system (CNS) disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Severe intercurrent illness or comorbidity
- Inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy up to and including grade 2
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (22 Sites)
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Memorial Hospital East — Shiloh, Illinois
- University of Kansas Clinical Research Center — Fairway, Kansas
- University of Kansas Cancer Center — Kansas City, Kansas
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center-South County — St Louis, Missouri
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York
- Montefiore Medical Center-Einstein Campus — The Bronx, New York
- Montefiore Medical Center-Weiler Hospital — The Bronx, New York
- Montefiore Medical Center - Moses Campus — The Bronx, New York
- University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio
- University of Cincinnati Cancer Center-West Chester — West Chester, Ohio
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt Breast Center at One Hundred Oaks — Nashville, Tennessee
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.