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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.

Phase 1RecruitingNational Cancer Institute (NCI)NCT05372640Data as of May 2026

Treatment: Abemaciclib · BET Bromodomain Inhibitor ZEN-3694This 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.

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Extracted 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

Min 0 prior lines

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

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