Completed Cancer NIHR-supported project Digestion, Kidneys & Other Organs

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumours

In plain English

AI plain-English summary

Doctors are testing a new drug, GSK5733584, that delivers a toxic payload directly to cancer cells by binding to a protein called B7-H4 found on their surface. This early-stage clinical trial is for patients with advanced solid tumours—breast, ovarian, and others—whose available treatments have stopped working. The drug is an antibody-drug conjugate, a type of precision therapy designed to kill cancer cells while sparing healthy tissue. The study has two phases: Phase 1a will find a safe dose, and Phase 1b will test that dose specifically in breast and ovarian cancer patients. Participants receive the drug by infusion until their disease worsens, side effects become unacceptable, or they withdraw. If the drug proves safe and shows signs of shrinking tumours, it could offer a new treatment option for people with few remaining choices. The study is open-label, meaning both patients and doctors know who receives the drug. All participants are followed for safety for 90 days after their last dose, and those in Phase 1b are also checked every 12 weeks for survival.

View original technical description
This research study is being done to learn more about an investigational treatment, GSK5733584 in its treatment of patients with advanced solid tumours. GSK5733584, are a new class of drug, called antibody-drug conjugate. GSK5733584 is an antibody that binds to a target called B7-H4 which kills the cancer cells. This study will look at how the body reacts to, how the body uses the GSK5733584 and how safe this medicine is at different doses in participants with advanced solid tumours. 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 Phase 1a and Phase1b. In Phase 1a, the study doctors will identify a safe dose and in Phase 1b, the chosen dose will be further studied in participants with breast and ovarian cancer. 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 received any prior chemotherapy or radiation treatment and/or have a serious and unstable medical conditions related to other organs. Participants will receive the GSK5733584 infusions into a vein, until disease progression, unacceptable toxicity, death, or withdrawal. All the participants will continue to receive safety follow-up until 90 days after the last dose (Phase 1a) and they will be additionally followed up every 12 weeks after the last dose for survival status (Phase 1b). The study will be conducted in accordance with the protocol and considering international ethical guidelines.

Researchers

Rowan Miller (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors
223559 - A Phase 1/2 multi-cohort study of GSK5733584 in combination with anti-cancer therapies for advanced solid tumours
GSK 222730 - A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors
GSK223559 - A Phase 1/2 multi-cohort study of GSK5733584 in combination with anti-cancer therapies for advanced solid tumours
A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

Original classification

Cancer

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