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Testing ZEN003694 with Capecitabine for Metastatic or Unresectable Cancers

This study is testing a new anti-cancer drug, ZEN003694, when added to the usual chemotherapy drug, capecitabine, for patients with cancer that has spread (metastatic) or cannot be removed by surgery (unresectable). This includes colorectal cancer and other solid tumors that have progressed after standard treatments. ZEN003694 works by blocking certain proteins that help cancer cells grow, while capecitabine is a chemotherapy that kills cancer cells. The main goals are to find out if this combination is safe, what side effects it causes, and to determine the highest safe dose (maximum tolerated dose) for future studies. We also want to see if the combination shows any anti-tumor activity. This study is currently enrolling about 30 participants aged 18 and older.

Study design
This is a dose-escalation study, meaning participants will receive increasing doses of ZEN003694 with capecitabine to find the safest and most effective amount. It is a single-arm study, meaning all participants receive the same treatment combination.
What's involved
You would take ZEN003694 and capecitabine by mouth, with cycles repeating every 21 days. You would undergo CT or PET/CT scans, blood tests, and potentially biopsies during screening and while on the study.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 30 days after your last dose of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05803382

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~30 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:BET Bromodomain Inhibitor ZEN-3694Biopsy ProcedureBiospecimen CollectionCapecitabineComputed TomographyMagnetic Resonance Imaging

At a glance

Recruiting sites
15 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 30 days after last dose
+2 more outcomes measured

Conditions

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

Explore related trials

Colorectal CarcinomaSolid Neoplasm

NCT05803382

Where you'd take part

This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Montefiore Medical Center - Moses Campus

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, Californiastudy coordinator listed

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, Californiastudy coordinator listed

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Floridastudy coordinator listed

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Dennis Hsu · PRINCIPAL_INVESTIGATOR · University of Pittsburgh Cancer Institute LAO

Who to contact

Site Public Contact
[email protected]
877-827-8839
Email the study team

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Eligibility criteria

Inclusion

Dose Escalation additional criteria: Patients must have histologically confirmed cancer that is metastatic or unresectable and must have progressed on standard therapies which would have included fluorouracil (5-FU) or capecitabine
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 standard therapies which would have included 5-FU or capecitabine
Dose Expansion additional criteria: Willingness and ability to undergo pre- and on- treatment biopsies
Patients must have measurable disease
Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 (ZEN-3694) in combination with capecitabine in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky \>= 60%)
Availability of archival tumor tissue at the time of patient enrollment for molecular profiling studies
Prior to study dosing, previous systemic therapy must have been completed for at least five half-lives or 2 weeks, whichever is shorter
Absolute neutrophil count \>= 1,000/mcL
Platelets \>= 100,000/mcL
Total bilirubin =\< 1.5 institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
Glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients should be New York Heart Association Functional Classification of class 2B or better
The effects of ZEN003694 (ZEN-3694) and capecitabine on the developing human fetus are unknown. For this reason and because BET inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Women of child-bearing potential and men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of ZEN003694 (ZEN-3694) and capecitabine administration
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Exclusion

Previous treatment with BET inhibitors
History of inability to tolerate capecitabine at the projected treatment dose on this trial
Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
Treatment for HIV, hepatitis B or hepatitis C only if this interferes with the current treatment (e.g. through drug-drug interactions)
Gastrointestinal pathology or history that adversely impacts the ability to take or absorb oral medication
Hepatic tumor burden \> 30% or peritoneal carcinomatosis
Untreated/uncontrolled central nervous system (CNS) disease
Known dihydropyrimidine dehydrogenase (DPD) deficiency
Severe intercurrent illness or comorbidity
Inability to comply with the protocol and/or not willing or who will not be available for follow-up assessments
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy up to and including grade 2
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 (ZEN-3694) or other agents used in study
Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Strong inhibitors of CYP3A4 must be discontinued at least 7 days, and inducers 14 days prior to the first dose of ZEN003694 and capecitabine. Substrates of CYP1A2 with narrow therapeutic window must be avoided while taking ZEN003694
Pregnant women are excluded from this study because ZEN003694 (ZEN-3694) is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694 (ZEN-3694), breastfeeding should be discontinued if the mother is treated with ZEN003694 (ZEN-3694). These potential risks may also apply to other agents used in this study

What this trial measures

  • Incidence of adverse eventsUp to 30 days after last dose

    Adverse events and serious adverse events will be tabulated for each dose levels. As per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, the term toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

  • Maximum tolerated dose (MTD)During the first cycle of therapy (Cycles = 21 days)

    Defined as the highest dose level with no more than 1/6 dose-limiting toxicity.

  • Recommended phase 2 dose (RP2D)Up to 30 days after last dose

    Will be determined based on the MTD and later cycle adverse event (AE) rates.