Phase 3 Trial Comparing Mocertatug Rezetecan to Chemotherapy in Women With Endometrial Cancer After Prior Platinum Chemotherapy and Immunotherapy

What this Trial Is About

Researchers are evaluating how well mocertatug rezetecan Mo-Rez works compared to standard chemotherapy treatments in women with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy. This Phase 3 study also examines the safety and tolerability of Mo-Rez and aims to better understand the main side effects of the drugs. The trial is sponsored by GlaxoSmithKline and involves adult female participants. Participants are randomly assigned to one of two groups one group receives mocertatug rezetecan, and the other receives standard of care chemotherapy with either paclitaxel or doxorubicin, depending on the investigators choice. The study follows a parallel design with single masking. Treatments are given according to the study protocol, and the trial includes up to approximately 97 weeks of follow-up for primary outcomes and up to 156 weeks for secondary outcomes. During the study, participants will have regular assessments including scans reviewed by blinded independent central reviewers, quality of life questionnaires, and monitoring for adverse events through laboratory tests, vital signs, and ECGs. Researchers will measure objective response rates, progression-free survival, overall survival, and other treatment outcomes. The study tracks safety events, antibody responses to Mo-Rez, and changes in participants quality of life over time. Participation may last several years, with ongoing evaluations to monitor health and treatment effects.

A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)