RecruitingPhase 1NCT05950464

Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer

A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

65 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two experimental drugs (M1774 and ZEN-3694) in people with recurrent ovarian or endometrial (uterine) cancer. Researchers are testing different dose combinations to find the safest and most effective approach, particularly in cancers with or without a gene called ARID1A. **You may be eligible if...** - You are 18 or older with recurrent clear cell, endometrioid ovarian cancer, or endometrial cancer, or recurrent platinum-resistant high-grade serous ovarian cancer - You have received 1 to 3 prior chemotherapy regimens - Your cancer is measurable on imaging - Your blood counts, kidney, and liver function meet required levels - You are able to swallow oral medications **You may NOT be eligible if...** - You are currently taking another investigational drug - You have previously received ATR, ATM, BET, or PI3K inhibitor drugs - You are taking proton pump inhibitors (like omeprazole) that cannot be stopped - You have serious heart conditions or prolonged QT interval on your heart tracing (ECG) - You have a history of serious DNA repair disorders - You are pregnant or breastfeeding 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

DRUGBET Bromodomain Inhibitor ZEN-3694

Given PO

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGTuvusertib

Given PO

PROCEDUREX-Ray Imaging

Undergo x-ray


Locations(14)

Augusta University Medical Center

Augusta, Georgia, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Case Western Reserve University

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

NRG Oncology

Philadelphia, Pennsylvania, United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05950464


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