Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer (NRG-GY031)
Recruiting
18-99 years
Female
Phase
1
1 Location
Brief description of study
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.The target population for this study is 6.We will utilize the CIRB as the IRB of record.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Recurrent Ovarian and Endometrial Cancer
-
Age: Between 18 Years - 99 Years
-
Gender: Female
Inclusion Criteria:
- Patients must have pathologically confirmed:
- PART I: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% morphology of clear cell and endometrioid required), recurrent clear cell and low grade endometrioid endometrial carcinoma (The International Federation of Gynecology and Obstetrics [FIGO] grade 1), or recurrent platinum resistant high grade serous ovarian carcinoma
- NOTE: platinum-resistant disease is defined as progression within < 6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy
- NOTE: Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.
- NOTE: Patients with recurrent endometrial carcinoma must not be eligible for or decline treatment with curative intent.
- PART II: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% tumor morphology of clear cell and endometrioid required). Recurrent clear cell or FIGO Grade 1 endometrioid endometrial carcinoma. Next Generation Sequencing (NGS) by Clinical Laboratory Improvement Act (CLIA) approved lab required for ARID1A status. Tumor will be determined as ARID1A pathologic alteration or likely pathologic alteration (Cohort I) or ARID1A wildtype by NGS (Cohort II). The number of patients in PART II cohort with clear cell or endometrioid EMCA will be capped at 33% (5 patients per cohort). Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.
- Age >= 18
- Eastern Cooperative Oncology Group (ECOG) Performance Status of =< 2
- Prior Treatment
- 1-3 prior cytotoxic therapies
- NOTE: For platinum-resistant HGSOC (PART 1) may have received up to 3 prior cytotoxic therapies after developing platinum resistant disease.
- Subjects with microsatellite instability- high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.
- Unlimited prior hormonal therapy, targeted therapy (including immunotherapy), and/or antiangiogenic therapy will be permitted.
- Washout periods (due to risk of myelosuppression):
- Cytotoxic chemotherapy - 3 weeks.
- Radiation therapy - 2 weeks (NOTE: patients with radiation to > 25% of the bone marrow are NOT eligible).
- Disease status:
- For PART I, evaluable disease or measurable disease required. NOTE: evaluable disease: defined as disease related abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions.
- For PART II, measurable disease by RECIST 1.1 is required. Patients will be required to undergo biopsy, which may be a non-target lesion but should not be the only RECIST measurable lesion.
NOTE: Patients for PART II are required to undergo paired tumor biopsies. If at time of biopsy the biopsy is deemed unsafe by interventional radiology or attempted and is unsuccessful, patients may still enroll.
Updated on
01 Aug 2024.
Study ID: 854583
Find a site
,
You have contacted , on
Your message has been sent to the study team at ,
A copy of the message has been sent to your email
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
