Clinical trialNCT05372640RecruitingPhase 1Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment45Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Malignant Solid NeoplasmMetastatic NUT CarcinomaUnresectable Breast Carcinoma+2 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Jia Luo
Dana-Farber - Harvard Cancer Center LAO
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Keck Medicine of Usc Koreatown
Los Angeles, California, United States
Robert Hsu
Recruiting
Los Angeles General Medical Center
Los Angeles, California, United States
Robert Hsu
Recruiting
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Robert Hsu
Recruiting
Usc Norris Oncology/hematology-Newport Beach
Newport Beach, California, United States
Robert Hsu
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Jia Luo
Recruiting
Upmc Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Liza C. Villaruz
Recruiting
Ut Md Anderson Cancer Center
Houston, Texas, United States
Sarina A. Piha-Paul
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AbemaciclibBET Bromodomain Inhibitor ZEN-3694

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Aug 2023
Primary completion: 7 Jun 2027
Completion: 7 Jun 2027
Last update posted: 31 Jul 2026
Registered enrollment: 45
Registry id: NCT05372640

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.