A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Primary Objectives: To evaluate the efficacy of INCB123667 monotherapy in participants with PROC with cyclin E1 overexpression (Cohort 1). Primary Endpoints: Objective response by IRC, defined as having a confirmed best overall response of CR or PR, as determined by IRC assessment per RECIST v1.1. Secondary Objectives: To further assess the efficacy of INCB123667 monotherapy in participants with PROC with cyclin E1 overexpression (Cohort 1). To evaluate the safety and tolerability of INCB123667 monotherapy in participants with PROC. Secondary Endpoints: DOR by IRC, defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first. PFS by IRC, defined as the time from the date of first dose of study drug until the earliest date of disease progression as determined by IRC assessment per RECIST v1.1, or death due to any cause, whichever occurs first. OS, defined as the time from the date of first dose of study drug until death due to any cause. Objective response by investigator, defined as having a confirmed best overall response of CR or PR, as determined by investigator assessment per RECIST v1.1. DOR by investigator, defined as the time from the earliest date of CR or PR contributing to a subsequently confirmed CR or PR until the earliest date of disease progression, as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first. PFS by investigator, defined as the time from the date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment per RECIST