Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers

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 antim

Trial Details

NCT ID
NCT05803382
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • BET Bromodomain Inhibitor ZEN-3694
  • Biopsy Procedure
  • Biospecimen Collection
  • Capecitabine
  • Computed Tomography
  • Magnetic Resonance Imaging
Locations (sample)
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Shiloh, Illinois, United States|38.56144,-89.89732
  • Fairway, Kansas, United States|39.02223,-94.6319

Key Eligibility Criteria

  • Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed…
  • Dose Escalation additional criteria specifically for colorectal cancer (CRC) patients: Willingness and ability to undergo a pre-treatment biopsy
  • Dose Expansion additional criteria: Patients must have histologically confirmed CRC that is metastatic or unresectable and must have progressed on …
  • Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies

For full eligibility, visit ClinicalTrials.gov.

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