Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05803382 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
20
Study locations

NCT05803382 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05803382, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Colorectal Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Metastatic Malignant Solid Neoplasm Metastatic Colorectal Carcinoma Stage IV Colorectal Cancer AJCC v8 Unresectable Malignant Solid Neoplasm Unresectable Colorectal Carcinoma

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)

3,257 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (85% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT05803382 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Missouri, New York, Kansas.

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.

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).

Who is sponsoring clinical trial NCT05803382?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Metastatic Malignant Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Metastatic Malignant Solid Neoplasm

All registered trials for this condition

Metastatic Colorectal Carcinoma

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.