Phase 2 Study of Lorigerlimab to Treat Women with Platinum-Resistant Ovarian or Clear Cell Gynecologic Cancers

What this Trial Is About

Researchers are evaluating lorigerlimab, a bispecific DART protein targeting PD-1 and CTLA-4, in participants with platinum-resistant ovarian cancer or clear cell gynecologic cancers. This open-label Phase 2 study aims to assess the effectiveness and safety of lorigerlimab in these advanced solid tumors. Approximately 80 participants will be enrolled to explore its impact on tumor response and disease control. Participants will receive lorigerlimab through intravenous infusion every 21 days at doses of either 3 mgkg or 6 mgkg depending on their study cohort. Treatment will continue until cancer progression, unacceptable side effects, withdrawal, or study completion. Different cohorts include those with platinum-resistant ovarian cancer and clear cell gynecologic cancers, with dosing tailored to each group. During the study, participants will be closely monitored with physical exams and lab tests every treatment cycle. Tumor assessments will occur about every 9 weeks in the first year and every 12 weeks afterward. Safety follow-up will happen within 30 days after stopping treatment. Those stopping treatment for reasons other than progression will have continued tumor marker and imaging checks every 12 weeks. Participants whose cancer progresses will enter a 6-month survival follow-up. The primary measure is the objective tumor response rate assessed by RECIST criteria over up to 2 years.

A Study of Lorigerlimab in Participants With Advanced Solid Tumors