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Phase 1
Phase 2
Age: 18Years +
All Genders
ID06885034

Testing the Safety and Effectiveness of GSK5764227 Alone or with Other Treatments in People 18 and Older with Advanced Unresectable or Metastatic Gastrointestinal Cancers

Led by GlaxoSmithKline · Updated on 2026-08-03

451

Participants Needed

85

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new medicine called Risvutatug Rezetecan also known as GSK5764227 or Ris-Rez in people worldwide who have advanced gastrointestinal cancers that cannot be removed by surgery. These participants have previously received treatment for their cancer. The study aims to understand how well this medicine works, how safe it is, and how the body processes it. Participants will receive Risvutatug Rezetecan alone or combined with other drugs, including Drug 1, Drug 2, Drug 3, and Drug 4. The study includes different dosing groups and combinations to assess the medicines effects. Treatments will be given according to the assigned group, and the study follows a randomized design without masking. During the trial, participants will undergo regular assessments including scans and laboratory tests to monitor cancer response and safety. Researchers will measure outcomes such as tumor response rate, duration of response, progression-free survival, and changes in vital signs and blood tests. The study will also track side effects and how the medicine is processed by the body over up to approximately 37 months. Participants will be closely monitored throughout the study period, which lasts several years.

CONDITIONS

Brief Title

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)

Research Team

U

US GSK Clinical Trials Call Center

E

EU GSK Clinical Trials Call Center

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