A Phase 2 Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 1)

Brief description of study

This is a phase 2 study to test whether the new study medicine, INCB123667 (CDK2 inhibitor), is safe and effective in patients with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer whose tumors express the protein called cyclin E1.

Patients will be divided into three groups based on Cyclin E expression levels. All patients will receive the study medicine INCB123667, oral medication, at a dose of 50 mg on each day of a 28-day cycle. The study team will collect blood samples from all patients to check how their bodies respond to the study medication. A special blood test will be conducted to monitor changes in tumor DNA released into the blood (ctDNA) over the course of treatment. CT scans will be done for all patients to see how the tumor size is changing in response to the study treatment. The study team will examine how effective the medicine is, and how long it takes for the cancer to come back in patients who receive the study medicine. All patients will be closely watched for potential side effects and safety concerns.


Clinical Study Identifier: s25-00622
ClinicalTrials.gov Identifier: NCT07023627
Principal Investigator: Bhavana Pothuri.
Other Investigators: Christina Grace Wilson, Marina Stasenko, Michelle Diane Swanson Lightfoot, Erin Annette Reese, Whitfield B. Growdon, Sarah Saerohm Lee, Kathleen M Lutz, Leslie R Boyd.


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