In short
Clinical trials are studying GSK4524101A in adults with advanced or metastatic solid tumors, and in a breast cancer expansion group. The research looks at safety, tolerability, how the body handles the treatment, and early signs of anticancer activity, both alone and with niraparib.
Key points
- Clinical trials of GSK4524101A are studying adults with advanced or metastatic solid tumors, and a later expansion group with metastatic breast cancer. The study is Phase 1/2, so it first focuses on safety, tolerability, dose finding, and pharmacokinetics. It also looks for early anticancer activity, including when GSK4524101A is used with niraparib. The main breast cancer group includes people with gBRCAmut, HER2-negative, or HER2-low disease. The trial is completed and included 99 participants.
Trial overview
The clinical trial NCT06077877 studied GSK4524101A in adults with advanced or metastatic solid tumors, and it also studied GSK4524101A with niraparib. The study was Phase 1/2 and was completed with 99 participants.
The trial aimed to learn about safety, tolerability, pharmacokinetics (how the body handles a treatment), and early anticancer activity. It also looked for a dose that could be used in the study setting based on safety, available PK, and available pharmacodynamic information.
Who can join the study
In the dose-escalation part, the study enrolled adults with advanced or metastatic solid tumors who had already used all standard of care treatment options. The study also preferred participants who might benefit based on the trial's treatment approach.
In the dose-expansion part, the study enrolled adults with metastatic breast cancer that was gBRCAmut, HER2-negative, or HER2-low. These participants had completed at most 3 prior lines of therapy and were PARPi-naïve, which means they had not had a PARP inhibitor before.
What the study measures
The first part of the trial measured dose-limiting toxicities, which are side effects that are serious enough to limit the dose that can be given. It also measured treatment-emergent adverse events and serious adverse events, how long these events lasted, whether participants received all planned doses, and whether dose interruptions, dose reductions, or stopping treatment were needed because of side effects.
In the second part, the main outcome was confirmed objective response rate. This means the study checked how many participants had a confirmed tumor response, such as shrinkage of the cancer.
Study phases and study groups
This was a dose escalation and dose expansion study. Dose escalation means the researchers carefully tested increasing doses to find the maximum tolerated dose and the maximum tolerated dose for the combination with niraparib.
The study also included a food effect cohort, which means one group was used to see whether food changed how the treatment was handled by the body. The expansion part studied GSK4524101A with niraparib at a dose lower than, at, or near the tested combination dose, but not above it.
Key medical terms
- Solid tumors: cancers that form a lump or mass, rather than cancers of the blood.
- Metastatic: cancer that has spread to other parts of the body.
- Standard of care: the usual treatment doctors use for a disease.
- Pharmacokinetics: what the body does to a treatment after it is taken.
- Pharmacodynamic: how a treatment affects the body, as used in the trial description.
- Adverse event: any unwanted medical problem that happens during a study.
- Serious adverse event: an unwanted medical problem that is severe or needs urgent care.
- Objective response rate: the share of participants whose tumors respond in a confirmed way.