A Phase I/II study of GSK5733584 in combination with anti-cancer therapies for advanced solid tumors
Research type
Research Study
Full title
A Phase I/II Randomized Multi-Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 in Combination with Anti-Cancer Agents in Participants with Advanced Solid Tumors
IRAS ID
1010791
Contact name
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
This research study is being done to learn more about an investigational treatment, GSK5733584 when in combination with other anti-cancer drugs in the treatment of patients with advanced solid tumours.
GSK5733584 is an “antibody drug conjugate” that binds to a target called B7-H4 and initiates a process that kills the cancer cells.
This study will look at how the body reacts to, how the body uses GSK5733584, and how safe this medicine is at different doses in participants with advanced solid tumours when combined with other anti-cancer drugs. This may benefit people with advanced solid tumours by providing them with new treatment possibilities.
This is an open-label study; that means the study doctors and the participants both will be aware of the treatment given to the participants. The study consists of Parts A and B. In Part A, the study doctors will identify a safe dose of the combination of GSK5733584 with other anti-cancer drugs in participants with different tumour types. In Part B, the established dose of the combination will be further studied in participants specifically with endometrial and ovarian cancers.
Men and non-pregnant women can be included if they are aged 18 years or older and are diagnosed with advanced or solid tumours and available treatments have stopped working. Participants cannot be included if they have serious and unstable medical conditions related to other organs.
Participants will receive all treatments, individually, as infusion into a vein, once every three weeks until disease progression, unacceptable toxicity, death, or study withdrawal. All the participants will continue to receive safety follow-up until 90 days after the last dose. Participants in Part B will be followed up every 12 weeks after the last dose for survival status. The study will be conducted in accordance with the protocol and considering international ethical guidelines.REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0380
Date of REC Opinion
17 Feb 2025
REC opinion
Further Information Favourable Opinion