Actively Recruiting
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
36
Participants Needed
5
Research Sites
206 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 cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma. Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Combination therapy with ZEN003694 and etoposide and cisplatin or carboplatin and paclitaxel may be safe and effective in treating patients with NUT carcinoma.
CONDITIONS
Official Title
Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of NUT carcinoma confirmed by NUT protein expression or gene translocation testing in a certified laboratory
- Disease is metastatic, unresectable, or surgery unlikely to improve survival; prior surgery allowed for Phase 1
- Age 12 years or older; patients 12-17 years must weigh at least 40 kg
- ECOG performance status 0 to 2 for those 16 or older; Lansky score 50% or higher if under 16
- Measurable disease per RECIST 1.1 criteria; phase 1 patients may have evaluable disease without measurable lesions
- Ability to swallow and retain oral medications
- Adequate blood counts: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 125 x 10^9/L, hemoglobin ≥ 9.0 g/dL
- Albumin ≥ 2.5 g/dL
- Liver function tests within limits: total bilirubin ≤ 1.5 times upper limit of normal (ULN); AST/ALT ≤ 2.5 times ULN
- Kidney function with creatinine clearance ≥ 60 mL/min
- Blood clotting times PT/INR and PTT ≤ 1.5 times ULN
- QT interval under 450 ms; avoid medications that prolong QT
- HIV patients with undetectable viral load on stable therapy allowed if no drug interactions
- Hepatitis B patients must have undetectable viral load on treatment
- Hepatitis C patients must be cured or have undetectable viral load if on treatment
- Prior or concurrent malignancies allowed if not interfering with study, with restrictions for non-thoracic cohort
- Use of effective contraception for men and women of childbearing potential during and 4 months after study
- Negative pregnancy test within 7 days before treatment start for women of childbearing potential
- No recent cytotoxic chemotherapy, targeted therapy, or immunotherapy within 2 weeks or 5 half-lives, except prior EP or carboplatin/paclitaxel therapy with no required washout
- Previous radiation allowed after at least 1 week
- Major surgery allowed after at least 3 weeks
- Previous treatment toxicities resolved to grade 1 or baseline except certain mild side effects
- Non-thoracic cohort participants must lack BRD4-NUT fusion or have unknown status confirmed by testing
- Ability to understand and sign informed consent (or by legal representative if minor or impaired)
You will not qualify if you...
- Untreated central nervous system metastases; treated CNS metastases allowed if stable for 4 weeks and meeting other criteria
- Use of enzyme-inducing anticonvulsants without switching to non-inducing agents before study
- Presence of symptomatic or untreated leptomeningeal metastases or spinal cord compression
- Allergic reactions to ZEN003694 or similar agents
- Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmias, recent heart attack within 6 months, or psychiatric/social issues limiting compliance
- Gastrointestinal disorders affecting absorption of oral medications
- Use of other investigational agents
- Use of strong CYP3A4 inhibitors or inducers, or CYP1A2 substrates with narrow therapeutic windows; use of proton pump inhibitors
- Pregnancy or breastfeeding
- Therapeutic-dose anticoagulation with certain blood thinners; prophylactic doses allowed
- Radiation to more than 25% of bone marrow
- Significant cardiac abnormalities including arrhythmias, heart failure class II or higher, recent coronary events, cardiomegaly, hypertrophy, or cardiomyopathy
- Prior dose reductions of study drugs due to unacceptable toxicities
- Ineligibility for receiving etoposide and cisplatin or carboplatin and paclitaxel as judged by investigator
- Non-thoracic cohort excludes disease definitively originating in thoracic cavity except uncertain metastatic cases
- Prior treatment with BET inhibitors including ZEN003694 for non-thoracic cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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