NRG-GY031

Open to Accrual

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

Principal Investigator

Fiona Simpkins, MD

Status

Open to Accrual

Date Opened To Accrual

August 31, 2023

Disease Site

Gynecologic [GY] Uterine Corpus

Phase

Developmental Therapeutics

Yes

Primary Objective

To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) for combination of ATR inhibitor (M1774) and BET inhibitor (ZEN003694) in women with recurrent clear cell, endometrioid, and platinum resistant high grade serous ovarian carcinoma (HGSOC) and clear cell and endometrioid endometrial carcinoma irrespective of ARID1A status (PART I). To determine safety and tolerability in ARID1A pathogenic alteration (ARID1A^MUT) and ARID1A wildtype (ARID1A^WT) cohorts (ARID1A is an integral biomarker) in an expansion phase (PART II). To determine change in pharmacodynamic biomarker expression of ƔH2AX (for ATR inhibition, integral biomarker) from pre-treatment and on-treatment tumor samples in ARID1A^MUT and ARID1A^WT expansion cohorts by immunohistochemistry (IHC) (PART II).

Patient Population

Women with recurrent ovarian and endometrial cancer.

Target Accrual

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Forms

Investigator Resources

Study Memos

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.

Protocol Information