RecruitingPhase 1NCT05372640

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

A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors


Sponsor

National Cancer Institute (NCI)

Enrollment

45 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two cancer drugs — ZEN003694 and abemaciclib — used together for adults and teenagers (12–17) with advanced cancers including NUT carcinoma (a rare, aggressive cancer), breast cancer, and other solid tumors that are no longer responding to standard treatment. **You may be eligible if...** - You are 12 years or older (adolescents 12–17 must weigh at least 40 kg) - You have a confirmed cancer that is metastatic (spread) or cannot be surgically removed, and standard treatments are no longer working - You can swallow oral medications - Your organ function (blood, liver, kidneys, heart) meets study requirements - You are in reasonably good health (ECOG 0–2 for adults; Lansky score 50% or higher for those under 16) **You may NOT be eligible if...** - You have received chemotherapy, immunotherapy, or radiotherapy within the past 2 weeks - You have had major surgery within the past 3 weeks - You are taking strong CYP3A4 inhibitors or inducers (certain medications) or proton pump inhibitors - You have uncontrolled heart disease or a recent heart attack - You are pregnant or breastfeeding - You have impaired bowel absorption (e.g., Crohn's disease, total stomach removal) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

Given PO

DRUGBET Bromodomain Inhibitor ZEN-3694

Given PO

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREDiagnostic Imaging Testing

Undergo imaging evaluation


Locations(7)

Keck Medicine of USC Koreatown

Los Angeles, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05372640


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