OncoMatch/Clinical Trials/NCT05372640
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
Is NCT05372640 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Abemaciclib and BET Bromodomain Inhibitor ZEN-3694 for anatomic stage iii breast cancer ajcc v8.
Treatment: Abemaciclib · BET Bromodomain Inhibitor ZEN-3694 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Biomarker criteria
Required: NUTM1 ectopic expression
Ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) testing
Required: NUTM1 gene translocation
Detection of the NUT gene translocation as determined by fluorescence in situ hybridization (FISH) testing
Required: NUTM1 gene translocation
Detection of the NUT gene translocation as determined by either deoxyribonucleic acid (DNA) next-generation sequencing (NGS) or ribonucleic acid (RNA) sequencing
Disease stage
Required: Stage III, IV (AJCC v8)
Metastatic disease required
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; metastatic or unresectable
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Exception: must have recovered (CTCAE grade ≤ 1) from acute effects except for residual alopecia or grade 2 peripheral neuropathy
Patients who received chemotherapy must have recovered (CTCAE grade ≤ 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy
Cannot have received: radiotherapy
Exception: must have completed and fully recovered from acute effects; washout period of at least 14 days required between end of radiotherapy
Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy
Cannot have received: cytotoxic chemotherapy, immunotherapy, or other investigational therapy
Exception: within 2 weeks prior to entering the study
Participants who have had cytotoxic chemotherapy, immunotherapy, or other investigational therapy within 2 weeks prior to entering the study
Cannot have received: BET inhibitor therapy
Exception: two-week required washout period
There is a two-week required washout period for previous BET inhibitor therapy
Cannot have received: radiotherapy
Exception: within at least 2 weeks prior to entering the study. Stereotactic radiosurgery (SRS) within 1 week prior to entering the study will be allowed
Participants who have had radiotherapy within at least 2 weeks prior to entering the study. Stereotactic radiosurgery (SRS) within 1 week prior to entering the study will be allowed
Cannot have received: tyrosine kinase inhibitors (TKIs) or small molecules
Exception: within 5 half-lives or 1 week (whichever is shorter) of study entry
Participants who have received tyrosine kinase inhibitors (TKIs) or small molecules within 5 half-lives or 1 week (whichever is shorter) of study entry
Cannot have received: major surgery
Exception: within 3 weeks prior to entering the study
Participants who have had major surgery within 3 weeks prior to entering the study
Cannot have received: bone-targeted radionuclide
Exception: within 6 weeks of the first dose of ZEN003694
Patients who have had a bone-targeted radionuclide within 6 weeks of the first dose of ZEN003694
Lab requirements
Blood counts
Hemoglobin ≥ 8 g/dL (transfusion allowed, treatment must not begin earlier than the day after transfusion); ANC ≥ 1.5 x 10^9/L; Platelets ≥ 1 x 10^11/L
Kidney function
Serum or plasma creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 50 mL/min (≥ 18 years), or 60 mL/min/1.73m^2 (12-17 years, Schwartz formula)
Liver function
Total bilirubin ≤ 1.5 x institutional ULN for age (Gilbert's syndrome: ≤ 2.0 x ULN and direct bilirubin within normal limits permitted); AST/ALT ≤ 2.5 x institutional ULN for age
Cardiac function
NYHA Functional Classification class 2B or better; QTcF < 450 msec
Hemoglobin ≥ 8 g/dL... ANC ≥ 1.5 x 10^9/L; Platelets ≥ 1 x 10^11/L; Total bilirubin ≤ 1.5 x institutional ULN for age... AST/ALT ≤ 2.5 x institutional ULN for age; Serum or plasma creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 50 mL/min (≥ 18 years), or 60 mL/min/1.73m^2 (12-17 years, Schwartz formula); NYHA Functional Classification class 2B or better; QTcF < 450 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Keck Medicine of USC Koreatown · Los Angeles, California
- Los Angeles General Medical Center · Los Angeles, California
- USC / Norris Comprehensive Cancer Center · Los Angeles, California
- USC Norris Oncology/Hematology-Newport Beach · Newport Beach, California
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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