300148: A Phase 1b/2 study of GSK5764227 in combo with SoC or other agents in advanced solid tumours
Research type
Research Study
Full title
A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in combination with Standard of Care (SoC) or other agents in Participants with Advanced Solid Tumours.
IRAS ID
1013078
Contact name
Eleftheria Finger
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
Metastatic colorectal cancer (mCRC) and metastatic castration-resistant prostate cancer (mCRPC) are advanced cancers that have spread beyond their original location. mCRC affects the colon or rectum, and mCRPC is a type of prostate cancer. For these cancers, current treatments like chemotherapy often stop working, leaving individuals with few options.\n\nThis study aims to test a new medicine called GSK5764227. It delivers a toxin directly to cancer cells to destroy them while protecting healthy cells. Researchers will combine GSK5764227 with standard treatments to evaluate its safety, how the body reacts to it, and whether it shrinks or controls cancer.\n\nThe study has two parts. The main goal of Part 1 is to find the highest safe dose of GSK5764227 when used with other treatments. Researchers will monitor side effects or medical problems, measure how much of the medicine is in the body, and check if it shrinks or controls cancer. In Part 2, researchers will test that dose in a larger group of participants for further evaluation.\n\nThis is an open-label study, meaning both doctors and participants will know which treatment is given. It includes adult participants over the age of 18 with advanced colorectal or prostate cancer. In Part 1, participants will be divided into groups, with each group receiving GSK5764227 combined with a standard treatment for their cancer type.\n\nParticipants will be closely monitored for safety. While potential risks like nausea or low blood counts exist, the goal is to find a new treatment option. The potential benefits of this combination are expected to outweigh the risks of these advanced cancers
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0262
Date of REC Opinion
2 Feb 2026
REC opinion
Further Information Favourable Opinion