Actively Recruiting
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-11
65
Participants Needed
14
Research Sites
123 weeks
Total Duration
On this page
Sponsors
N
National Cancer Institute (NCI)
Lead Sponsor
N
NRG Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Pathologically confirmed recurrent clear cell or endometrioid ovarian carcinoma with at least 50% tumor morphology
- Recurrent clear cell or FIGO Grade 1 endometrioid endometrial carcinoma
- Platinum-resistant high grade serous ovarian carcinoma (progression within 6 months of platinum therapy) for Part I
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- 1 to 3 prior cytotoxic therapies received
- Prior immune checkpoint inhibitor therapy for MSI-H or dMMR endometrioid endometrial cancer
- Unlimited prior hormonal, targeted, immunotherapy, or antiangiogenic treatments
- Required washout periods from prior cytotoxic chemotherapy (3 weeks) and radiation therapy (2 weeks)
- Evaluable or measurable disease by imaging as required by study part
- Hemoglobin ≥ 9 g/dL without recent transfusion
- Absolute neutrophil count ≥ 1,500 cells/mm³
- Platelet count ≥ 100,000 cells/mm³
- Calculated creatinine clearance ≥ 50 mL/min
- Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), except Gilbert's disease patients may have up to 3 times ULN
- AST and ALT ≤ 3 times ULN
- New York Heart Association (NYHA) Class I or II if history or symptoms of cardiac disease
- Use of effective contraception for women of childbearing potential during and 6 months after treatment
- Patients with prior or concurrent malignancies that do not interfere with study assessments
- Patients with treated brain metastases stable for at least 1 month
- Ability to swallow oral medications without altering the product
- Controlled HIV, Hepatitis B virus, or Hepatitis C virus infections as specified
- Resolution of prior therapy toxicities to baseline or Grade 1 (except hypothyroidism up to Grade 2)
You will not qualify if you...
- Receiving any other investigational agents
- Prior treatment with ATR, ATM, CHK, BET, EZH2, or PI3K inhibitors
- Allergic reactions to compounds similar to ZEN-3694 or M1774
- Use of proton pump inhibitors within 7 days before starting the trial
- Corrected QT interval over 450 msec not corrected by electrolyte management or family history of long QT syndrome
- Severe active comorbidities including active infections requiring IV antibiotics and hereditary DNA repair disorders
- Pregnant or breastfeeding women
- Use of strong CYP3A4 inhibitors or inducers within 7 days before first dose
- Use of Factor Xa or Factor IIa inhibitors without approval
- Recent serious gastrointestinal bleeding or conditions affecting oral drug absorption
- Inability to discontinue drugs that strongly inhibit CYP3A4, CYP1A2, or affect hMATE1/hMATE2-K substrates
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
2
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
5
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
6
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
7
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
9
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
NRG Oncology
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
11
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
12
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
13
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
14
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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