RecruitingPhase 1NCT05803382

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

Phase I Trial of ZEN003694 (ZEN-3694) in Combination With Capecitabine in Patients With Solid Tumors

Sponsor

National Cancer Institute (NCI)

Enrollment

30 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a drug called ZEN003694 to the standard chemotherapy drug capecitabine (an oral chemo pill) can help treat metastatic or advanced cancers that have stopped responding to fluorouracil-based chemotherapy — with a primary focus on colorectal cancer. **You may be eligible if:** - You are 18 or older - You have a confirmed cancer that is metastatic or cannot be surgically removed - Your cancer has previously progressed on standard treatments including fluorouracil (5-FU) or capecitabine - You have measurable disease on imaging - Your blood counts, liver, and kidney function are within acceptable ranges - You are in reasonably good health (ECOG 0–2) **You may NOT be eligible if:** - You have not previously tried fluorouracil or capecitabine - You received another cancer therapy in the past 2 weeks (or within 5 drug half-lives) - You are under 18 years old - You are unwilling to undergo a tumor biopsy (required for some parts of the study) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBET Bromodomain Inhibitor ZEN-3694

Given PO

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGCapecitabine

Given PO

PROCEDUREComputed Tomography

Undergo CT and PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET/CT

Locations(22)

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Memorial Hospital East

Shiloh, Illinois, United States

University of Kansas Clinical Research Center

Fairway, Kansas, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT05803382

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