A Phase 1 Study of GSK5764227 in participants with advanced solid tumors
Research type
Research Study
Full title
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of GSK5764227 in Participants with Advanced Solid Tumors
IRAS ID
1010390
Contact name
Contact email
Sponsor organisation
GSK
Eudract number
2024-513663-10
Clinicaltrials.gov Identifier
Research summary
Cancer is a disease where cells grow out of control, often forming tumours, which are lumps of tissue that can spread throughout the body (metastasis). GSK5764227 is a new cancer medicine designed to target the B7-H3 protein, which is commonly found in many cancer cells.
By binding to this protein, GSK5764227 delivers a toxin directly to the cancer cells, effectively destroying them. This study aims to evaluate the safety and tolerability of GSK5764227, how the body absorbs it, and how effective it is in fighting cancer in participants with advanced solid tumours.
This is an open-label study, meaning both the doctors and participants will know the treatment being given. The study consists of Phase 1a and Phase 1b. In Phase 1a, doctors will gradually increase the dosage to assess its safety and effectiveness. Phase 1b will involve administering the determined safe dose to participants with various types of tumors.
Eligible participants include men and non-pregnant women aged 18 or older, diagnosed with previously treated advanced or metastatic solid tumors, and having at least one measurable tumor. Participants should be generally healthy, able to perform daily activities, expected to live more than 12 weeks, and possess good organ function. Those with throat cancer that has spread to nearby organs, serious unstable medical conditions, or a history of significant blood clot issues will be excluded.
Participants will receive GSK5764227 infused into a vein, with the dose calculated based on their weight. All participants will undergo safety follow-up for 90 days after their last dose, with survival follow-up conducted every 90 days thereafter.REC name
North East - York Research Ethics Committee
REC reference
24/NE/0174
Date of REC Opinion
17 Dec 2024
REC opinion
Further Information Favourable Opinion