Actively Recruiting
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
30
Participants Needed
22
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic or unresectable cancer that has progressed on standard therapies including fluorouracil or capecitabine
- For colorectal cancer patients, willingness and ability to undergo pre-treatment biopsy
- For dose expansion, willingness and ability to undergo pre- and on-treatment biopsies
- Presence of measurable disease
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky score of 60% or higher
- Availability of archival tumor tissue for molecular profiling at enrollment
- Completion of prior systemic therapy at least five half-lives or 2 weeks before study dosing
- Absolute neutrophil count of at least 1,000/mcL
- Platelet count of at least 100,000/mcL
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal
- AST/ALT less than or equal to 3 times institutional upper limit of normal
- Glomerular filtration rate of 50 mL/min/1.73 m2 or higher
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- For chronic hepatitis B, undetectable viral load on suppressive therapy if needed
- Patients with hepatitis C must be treated and cured or have undetectable viral load if currently on treatment
- Patients with treated brain metastases with no progression on follow-up brain imaging
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy assessment
- New York Heart Association Functional Classification of class 2B or better
- Women of child-bearing potential and men must agree to use adequate contraception before, during, and 6 months after treatment
- Ability to understand and willingness to sign informed consent or have legally authorized representative consent
You will not qualify if you...
- Previous treatment with BET inhibitors
- History of inability to tolerate capecitabine at projected treatment dose
- Use of oral Factor Xa or Factor IIa inhibitors (except low molecular weight heparin)
- Treatment for HIV, hepatitis B or C if it interferes with current treatment
- Gastrointestinal issues affecting ability to take or absorb oral medication
- Hepatic tumor burden greater than 30% or peritoneal carcinomatosis
- Untreated or uncontrolled central nervous system disease
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Severe intercurrent illness or comorbid conditions
- Inability or unwillingness to comply with protocol and follow-up assessments
- Residual toxicities greater than grade 1 from prior anti-cancer therapy except alopecia and neuropathy grade 2 or less
- Receiving any other investigational agents
- History of allergic reactions to ZEN003694 or similar agents
- Use of medications that are strong inhibitors or inducers of CYP3A4; must discontinue before study
- Pregnant or breastfeeding women due to potential risks of study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
2
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
4
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Active, Not Recruiting
5
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
6
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
8
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Active, Not Recruiting
9
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Active, Not Recruiting
10
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Active, Not Recruiting
11
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Active, Not Recruiting
12
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Active, Not Recruiting
13
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Active, Not Recruiting
14
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
15
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States, 10461
Actively Recruiting
16
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
17
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
18
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
19
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
20
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
21
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
Actively Recruiting
22
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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