Phase 2 Study of Sapanisertib and Serabelisib PIKTOR With Paclitaxel for Advanced or Recurrent Endometrial Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the combination of sapanisertib and serabelisib PIKTOR with paclitaxel in women with advanced or recurrent endometrial cancer. This Phase 2, open-label, single-arm study focuses on participants who have previously undergone systemic therapies, including platinum-based chemotherapy and immune checkpoint inhibitors, but whose cancer has not responded or returned. Participants will receive oral doses of sapanisertib and serabelisib together with intravenous paclitaxel. The study also includes a substudy that evaluates the combination of PIKTOR and paclitaxel with an insulin-suppressing diet. Treatment is administered under medical supervision at multiple centers. During the study, participants will undergo regular assessments to monitor tumor response, disease progression, survival, and treatment safety over extended periodsup to two years for response assessment and up to five years for survival and progression measures. Researchers will track adverse events and overall treatment tolerability. The total study duration and follow-up will allow detailed evaluation of treatment effects and participant health.

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer