Phase 1b2 Study Evaluating Safety and Effects of GSK5764227 Combined with Standard Treatments in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. This Phase 1b2 clinical study focuses on participants with advanced solid tumors, including metastatic colorectal and prostate cancers. The study aims to assess the safety, tolerability, how the body processes the drug, immune responses, and whether the treatment can shrink or control the cancer. Participants will receive GSK5764227 combined with standard treatments or other agents. The study includes specific groups for metastatic colorectal cancer and metastatic castration-resistant prostate cancer. Treatments include GSK5764227 along with drugs like bevacizumab, fluorouracil, leucovorin, and enzalutamide. The study is non-randomized and unblinded, with participants assigned to one of several experimental cohorts. During the trial, participants will be monitored for adverse events, dose-related toxicities, vital signs, body weight, laboratory tests, heart function, and overall performance status for up to about 31 weeks. Additional evaluations include measuring drug levels in the blood, immune responses against the drug, tumor response rates, disease control, and progression-free survival for up to approximately 112 weeks. The study will track safety and treatment effects closely throughout the participation period, which may last over two years for some assessments.

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors