OncoMatch/Clinical Trials/NCT05803382
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
Is NCT05803382 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BET Bromodomain Inhibitor ZEN-3694 and Capecitabine for metastatic colorectal carcinoma.
Treatment: BET Bromodomain Inhibitor ZEN-3694 · Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Tumor Agnostic
Disease stage
Required: Stage IV (AJCC v8)
Metastatic disease required
metastatic or unresectable; measurable disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: fluoropyrimidine (fluorouracil, capecitabine, 5-FU) — standard therapies
must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
Cannot have received: BET inhibitor
Previous treatment with BET inhibitors
Lab requirements
Blood counts
Absolute neutrophil count >= 1,000/mcL; Platelets >= 100,000/mcL
Kidney function
Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2
Liver function
Total bilirubin <= 1.5 institutional ULN; AST/ALT <= 3 x institutional ULN
Cardiac function
New York Heart Association Functional Classification of class 2B or better
Absolute neutrophil count >= 1,000/mcL; Platelets >= 100,000/mcL; Total bilirubin <= 1.5 institutional ULN; AST/ALT <= 3 x institutional ULN; GFR >= 50 mL/min/1.73 m^2; New York Heart Association Functional Classification of class 2B or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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