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RECRUITING Phase 1

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

NCT05803382 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Capecitabine
  • PROCEDURE Biopsy Procedure
  • DRUG BET Bromodomain Inhibitor ZEN-3694

Study Locations (20)

Missouri

  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters
  • Siteman Cancer Center at West County Hospital — Creve Coeur
  • Washington University School of Medicine — St Louis
  • Siteman Cancer Center-South County — St Louis
  • Siteman Cancer Center at Christian Hospital — St Louis

New York

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York
  • Montefiore Medical Center-Einstein Campus — The Bronx
  • Montefiore Medical Center-Weiler Hospital — The Bronx
  • Montefiore Medical Center - Moses Campus — The Bronx

Kansas

  • University of Kansas Clinical Research Center — Fairway
  • University of Kansas Cancer Center — Kansas City
  • University of Kansas Hospital-Westwood Cancer Center — Westwood

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange

Ohio

  • University of Cincinnati Cancer Center-UC Medical Center — Cincinnati
  • University of Cincinnati Cancer Center-West Chester — West Chester

Florida

  • UF Health Cancer Institute - Gainesville — Gainesville

Illinois

  • Memorial Hospital East — Shiloh

Oklahoma

  • University of Oklahoma Health Sciences Center — Oklahoma City

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2023-11-08
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05803382

The ClinicalTrials.gov registry entry for NCT05803382 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05803382 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Missouri, New York, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05803382 about?

NCT05803382 is a clinical study titled "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...

What is the current status of trial NCT05803382?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-11-08. Estimated completion is 2026-06-30.

What conditions does trial NCT05803382 study?

This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Unresectable Malignant Solid Neoplasm, Unresectable Colorectal Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05803382?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Biopsy Procedure (PROCEDURE), BET Bromodomain Inhibitor ZEN-3694 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05803382?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05803382 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial