New drug cocktail aims to fight Hard-to-Treat cancers
NCT ID NCT05803382
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 9 times
Summary
This early-phase trial is testing whether a new drug called ZEN003694, when added to the chemotherapy capecitabine, is safe for people with advanced solid tumors that have spread or can't be removed by surgery. About 30 participants will receive the combination to find the best dose and check for side effects. The goal is to see if this approach can control tumor growth in patients who have already tried standard treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZEN003694 (a BET protein inhibitor) and capecitabine (a chemotherapy drug)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early Phase I trial with only 30 people, so it is mainly checking safety and dosing. The combination may not shrink tumors or may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
15 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
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Locations
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Memorial Hospital East
ACTIVE_NOT_RECRUITINGShiloh, Illinois, 62269, United States
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Montefiore Medical Center - Moses Campus
RECRUITINGThe Bronx, New York, 10467, United States
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Montefiore Medical Center-Einstein Campus
RECRUITINGThe Bronx, New York, 10461, United States
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Montefiore Medical Center-Weiler Hospital
RECRUITINGThe Bronx, New York, 10461, United States
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
ACTIVE_NOT_RECRUITINGNew York, New York, 10032, United States
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Siteman Cancer Center at Christian Hospital
ACTIVE_NOT_RECRUITINGSt Louis, Missouri, 63136, United States
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Siteman Cancer Center at Saint Peters Hospital
ACTIVE_NOT_RECRUITINGCity of Saint Peters, Missouri, 63376, United States
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Siteman Cancer Center at West County Hospital
ACTIVE_NOT_RECRUITINGCreve Coeur, Missouri, 63141, United States
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Siteman Cancer Center-South County
ACTIVE_NOT_RECRUITINGSt Louis, Missouri, 63129, United States
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UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITINGIrvine, California, 92612, United States
Contact Email: •••••@•••••
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UF Health Cancer Institute - Gainesville
RECRUITINGGainesville, Florida, 32610, United States
Contact Email: •••••@•••••
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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University of Cincinnati Cancer Center-UC Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Email: •••••@•••••
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University of Cincinnati Cancer Center-West Chester
RECRUITINGWest Chester, Ohio, 45069, United States
Contact Email: •••••@•••••
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University of Kansas Cancer Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Clinical Research Center
RECRUITINGFairway, Kansas, 66205, United States
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University of Kansas Hospital-Westwood Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Vanderbilt Breast Center at One Hundred Oaks
RECRUITINGNashville, Tennessee, 37204, United States
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Vanderbilt University/Ingram Cancer Center
RECRUITINGNashville, Tennessee, 37232, United States
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Washington University School of Medicine
ACTIVE_NOT_RECRUITINGSt Louis, Missouri, 63110, United States
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