Phase 3 Study Comparing Puxitatug Samrotecan to Chemotherapy in Women with Advanced or Metastatic B7-H4 Selected Endometrial Cancer After Platinum-Based Chemotherapy and Anti-PD-1PD-L1 Treatment

What this Trial Is About

Researchers are evaluating the effectiveness and safety of puxitatug samrotecan compared to a physicians choice of chemotherapy doxorubicin or paclitaxel in adults with advanced or metastatic endometrial cancer that has progressed after platinum-based chemotherapy and anti-PD-1anti-PD-L1 therapy. This Phase III, randomized, open-label study focuses on participants selected for B7-H4 expression and who have received no more than two prior treatments for advanced disease. Participants will be randomly assigned to receive either puxitatug samrotecan intravenously every three weeks or chemotherapy chosen by their physician. Chemotherapy options include doxorubicin given intravenously every three weeks or paclitaxel administered intravenously on days 1, 8, and 15 in a 28-day cycle. The study plans to enroll about 700 participants worldwide and compare how long participants live without cancer progression and overall survival between the two groups. During the study, participants will have regular assessments of their cancer status and quality of life. These will include imaging scans to measure tumor response and tracking of symptoms and side effects. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and time until further treatments are needed. The study will last approximately three years for outcome assessment, with safety and quality of life monitored throughout.

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)