Phase 1B Study of Oral Combination Therapy with M1774 and ZEN-3694 for Recurrent Ovarian and Endometrial Cancer Focusing on ARID1A Mutation Status

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of a combination of two drugs, M1774 and ZEN-3694, in women with recurrent ovarian and endometrial cancer. This phase Ib trial focuses on patients with specific types of these cancers, including clear cell, endometrioid, and platinum-resistant high-grade serous ovarian carcinoma. The study also examines how these drugs affect certain biomarkers related to tumor growth and response, with a goal to understand their impact on disease progression and survival. Participants receive oral doses of M1774 once daily on specific days in each 28-day cycle, along with ZEN-3694 taken daily throughout each cycle. The study includes a dose-escalation phase to find the maximum tolerated dose and a dose-expansion phase to further evaluate safety and effects on biomarker expression. Patients undergo various assessments such as tumor biopsies, blood sample collections, and imaging scans including x-rays, CT, and MRI during the treatment phases. Throughout the trial, participants are closely monitored for side effects, changes in biomarker levels, and tumor response using imaging and laboratory tests. After completing the treatment, patients are followed every three months for two years and then every six months for three additional years to observe long-term outcomes. The study measures include dose-limiting toxicities, adverse events, biomarker changes, objective response rates, progression-free survival, and overall survival, providing comprehensive data over several years.

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