Actively Recruiting
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
45
Participants Needed
7
Research Sites
146 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 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). 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 overproduce BET protein. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ZEN003694 and abemaciclib may help shrink or stabilize cancer in patients with NUT carcinoma, breast cancer or other solid tumors.
CONDITIONS
Official Title
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic or unresectable malignancy without effective standard treatment
- For dose escalation: evaluable or measurable disease per RECIST 1.1
- For dose expansion: diagnosis of NUT carcinoma confirmed by approved tests and measurable disease per RECIST 1.1
- Any number of prior therapies allowed, including prior BET or CDK4/6 inhibitors
- Recovery from chemotherapy effects (CTCAE grade ≤1), except alopecia or grade 2 peripheral neuropathy
- Recovery from radiotherapy with at least 14 days since completion
- Prior surgical resection allowed
- Age ≥ 12 years; patients 12-17 years must weigh > 40 kg
- ECOG performance status ≤ 2 for ≥16 years; Lansky ≥ 50% if <16 years
- Hemoglobin ≥ 8 g/dL; neutrophils ≥ 1.5 x 10^9/L; platelets ≥ 1 x 10^11/L
- Total bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN or adequate creatinine clearance
- HIV patients on stable therapy with undetectable viral load
- HBV viral load undetectable if on suppressive therapy
- Treated or cured HCV infection with undetectable viral load
- Treated brain metastases stable for at least 1 month with disease outside CNS
- Prior or concurrent malignancy not interfering with study
- NYHA functional class 2B or better
- Ability to swallow and retain oral medications
- Agreement to use adequate contraception; negative pregnancy test for women of childbearing potential
- Ability to understand and sign informed consent; assent process for minors
You will not qualify if you...
- Cytotoxic chemotherapy, immunotherapy, or investigational therapy within 2 weeks prior; 2-week washout for prior BET inhibitors
- Radiotherapy within 2 weeks prior, except stereotactic radiosurgery within 1 week allowed
- Major surgery within 3 weeks prior
- Tyrosine kinase inhibitors or small molecules within 5 half-lives or 1 week prior
- Receiving other investigational agents
- Allergic reactions to ZEN003694 or abemaciclib or similar compounds
- Use of strong CYP3A4 inhibitors or inducers within 7 days prior
- Uncontrolled illness including active infection, severe heart or lung conditions, severe renal impairment, or certain gastrointestinal conditions
- Use of proton pump inhibitors; restrictions on acid-reducing agents
- Pregnant or breastfeeding women
- QTcF interval ≥ 450 msec on ECG
- Use of Factor Xa or IIa inhibitors (except low molecular weight heparin)
- Radiation to > 25% of bone marrow
- Bone-targeted radionuclide therapy within 6 weeks prior
- Recent myocardial infarction or unstable angina within 6 months
- Gastrointestinal impairment affecting drug absorption
- History of serious cardiac arrhythmias or sudden cardiac arrest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Keck Medicine of USC Koreatown
Los Angeles, California, United States, 90020
Actively Recruiting
2
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
4
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
5
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
7
M D Anderson Cancer Center
Houston, Texas, United States, 77030
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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