Table of contents
- Trial overview
- Gastrointestinal tumor study
- Relapsed small cell lung cancer study
- Combination study in advanced solid tumors
- What the trials measure
- Who can participate
Trial overview
Three interventional studies are investigating GSK5764227 in people with cancer.[1][2][3] The trials are authorised and include Phase 1, Phase 1b/2, and Phase 3 research.[1][2][3] They are studying advanced gastrointestinal tumors, relapsed small cell lung cancer, and other advanced solid tumors.[1][2][3]
Gastrointestinal tumor study
NCT06885034 is a Phase 1 study in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors.[1] The study includes people with colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC), which is a common type of pancreatic cancer.[1] It has an enrollment of 316 participants and is authorised.[1]
The brief summary says the study has separate parts for CRC and PDAC.[1] Part 1A in CRC looks at two dosing schedules, described as Q3W and Q2W, which mean every 3 weeks and every 2 weeks.[1] Part 1B looks at GSK5764227 in advanced unresectable PDAC.[1]
Relapsed small cell lung cancer study
The Phase 3 study 2025-521627-78-00 is a multicenter, randomized, open-label trial in participants with relapsed small cell lung cancer (SCLC).[2] Randomized means participants are assigned to study groups by chance, and open-label means both the study team and the participant know which treatment is given.[2] This study compares GSK5764227 with topotecan, a standard treatment used in the trial.[2]
The study aims to compare antitumor activity and includes 300 participants.[2] Its main outcomes are objective response rate and overall survival.[2] Objective response rate measures how many participants have a confirmed complete response or partial response, meaning the cancer disappears or shrinks enough to count as a response.[2]
Combination study in advanced solid tumors
The Phase 1b/2 study 2025-522274-37-00 is testing GSK5764227 with standard of care (SoC) or other agents in participants with advanced solid tumors.[3] The study is authorised and plans to enroll 72 participants.[3] Its goal is to find the maximum tolerated dose (MTD) and maximum administered dose (MAD), and to evaluate safety and tolerability.[3]
Maximum tolerated dose means the highest dose that people can take without too many serious side effects, while maximum administered dose means the highest dose actually given in the study.[3] The listed treatments include GSK5764227 plus several standard cancer medicines, showing that the study is looking at combination treatment strategies.[3]
What the trials measure
The gastrointestinal tumor study uses confirmed ORR as its primary outcome, defined as the proportion of participants with confirmed complete response or partial response by investigator review using RECIST 1.1.[1] RECIST 1.1 is a standard way to measure how tumors change on scans.[1]
The Phase 3 lung cancer study measures ORR by BICR assessment and overall survival.[2] BICR means blinded independent central review, which is a careful review by independent experts who do not know which treatment the participant got.[2]
The combination study measures safety outcomes such as adverse events, serious adverse events, adverse events of special interest, and adverse events that lead to dose changes.[3] It also tracks vital signs, body weight, lab tests, heart function by ECG, and ECOG performance status.[3] ECOG performance status is a scale that shows how well a person can do daily activities.[3]
Who can participate
These studies are for people with specific advanced cancers, not for healthy volunteers.[1][2][3] The groups named in the trial data include people with previously treated advanced unresectable or metastatic gastrointestinal solid tumors, relapsed small cell lung cancer, and advanced solid tumors.[1][2][3] Each study has its own entry rules, so eligibility depends on the exact cancer type, prior treatment, and other study requirements.[1][2][3]
