RecruitingPhase IEN original

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony nowotwór, który się rozprzestrzeniał lub nie można go usunąć chirurgicznie, a standardowe leczenie nie działa lub go nie ma
  • Wymierny nowotwór widoczny w badaniach obrazowych (RECIST 1.1)
  • Potwierdzona diagnoza raka NUT na podstawie testów genetycznych w certyfikowanym laboratorium
  • Dowolna liczba poprzednich leczań chemioterapią, w tym inhibitory BET i inhibitory CDK4/6
  • Wiek co najmniej 12 lat (dzieci 12-17 lat muszą ważyć powyżej 40 kg)
  • Dobry ogólny stan zdrowia - wynik ECOG ≤ 2 (dla osób ≥16 lat)
  • Wystarczająca liczba komórek krwi: hemoglobina ≥ 8 g/dL, neutrofile ≥ 1,5 x 10⁹/L, płytki ≥ 1 x 10¹¹/L
  • Prawidłowa funkcja wątroby: bilirubina całkowita ≤ 1,5 x norma laboratorium

Simplified criteria — AI translation

Trial details

Minimum age
12 Years
Last updated (source)
June 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (7)

Keck Medicine of USC Koreatown

Los Angeles, United States

Los Angeles General Medical Center

Los Angeles, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, United States

Dana-Farber Cancer Institute

Boston, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, United States

UT MD Anderson Cancer Center

Houston, United States

Trial contact

Site Public Contact

Robert Hsu

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Jia Luo

PRINCIPAL_INVESTIGATOR

Site Public Contact

Liza C. Villaruz

PRINCIPAL_INVESTIGATOR

Sarina A. Piha-Paul

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.