Phase 12 Study of Mocertatug Rezetecan Combined With Anti-Cancer Treatments for Advanced Solid Tumors

What this Trial Is About

Researchers are investigating new treatment options for people with advanced solid tumors, which are cancers that have spread to other parts of the body and often resist current therapies. This study focuses on evaluating the safety, tolerability, how the body processes, and effectiveness of Mocertatug Rezetecan Mo-Rez when combined with other anti-cancer medicines for participants who have not responded to standard treatments, cannot tolerate them, or have no effective options available. The study is a Phase 12 randomized, multi-cohort clinical trial sponsored by GlaxoSmithKline. Participants will receive Mo-Rez given through an intravenous IV infusion alone or combined with other cancer drugs such as Dostarlimab or Bevacizumab, depending on their specific type of cancer and study group. The study has two main modules one focusing on endometrial cancer treated with Mo-Rez plus Dostarlimab, and another for ovarian cancer treated with Mo-Rez with or without Bevacizumab. Treatment cycles and dosing schedules will be followed as per study protocols, with ongoing monitoring throughout the treatment period. During the trial, participants will undergo regular assessments including scans to measure tumor response, laboratory tests, vital sign monitoring, and evaluations of side effects. Researchers will track dose limiting toxicities, adverse events, and clinical activity such as tumor response rates over several months. Blood samples will be collected to study how Mo-Rez is processed in the body and to monitor immune responses. The study will last until the completion date in 2028, with participants monitored regularly to assess safety and treatment effects.

A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)