In short
Clinical trials are investigating GSK5460025A in people with dMMR/MSI-H solid tumors, including colorectal cancer. These studies aim to check safety, tolerability, dose, and early signs of anti-cancer activity, both alone and with other cancer treatments. The trial includes adults with specific solid tumors, and one part also looks at colorectal and endometrial cancer.
Key points
- GSK5460025A is being studied in a Phase 1/2 clinical trial in people with dMMR/MSI-H solid tumors. The study includes colorectal cancer and also looks at endometrial cancer in one part. Researchers are checking safety, tolerability, dose, and early anti-cancer activity. The trial measures side effects such as dose limiting toxicities and treatment-emergent adverse events, plus tumor response. GSK5460025A is being tested alone and also with other anti-cancer agents. The trial is authorised and plans to enroll 47 participants.
Trial overview
This study is a Phase 1/2 trial of GSK5460025A in people with dMMR/MSI-H solid tumors, including colorectal cancer. The trial is designed to look first at safety and dose, then at early signs that the treatment may help shrink tumors.
The study is interventional, which means participants receive a study treatment rather than only being observed. The trial status is Authorised, and the planned enrollment is 47 participants.
Who can join the study
The main target population is people with dMMR/MSI-H solid tumors. The trial title also shows a focus on solid tumors, and the brief summary names colorectal cancer for one part of the study and endometrial cancer for another part.
Based on the trial data, this study is aimed at people whose cancer fits these tumor features and cancer types, rather than a general cancer population.
What the study measures
The first part of the study checks dose limiting toxicities, which are side effects that may stop the dose from being increased. It also measures treatment-emergent serious adverse events and other treatment-emergent adverse events, which are health problems that appear after treatment starts.
Other safety measures include how long these side effects last and whether dose changes are needed because of side effects. These outcomes help researchers decide the recommended dose for expansion and/or the maximum tolerated dose.
The second part measures Objective Response Rate, or ORR, which is the percentage of participants with a confirmed complete response or partial response. In simple terms, this shows how many tumors fully disappear or shrink enough to count as a response under the study rules.
Study parts and treatment approach
Part 1 studies GSK5460025A as monotherapy, meaning it is given alone. In this part, the main goal is to find out if the treatment is safe enough and what dose should be used for later study.
Part 2 looks at early anti-tumor activity in colorectal cancer and, separately, endometrial cancer. The trial title also says GSK5460025A may be studied alone or in combination with other anti-cancer agents, so the research plan includes both single-drug and combination approaches.
Trial phase and status
This is a Phase 1/2 study, so it combines early safety testing with early effectiveness testing. Phase 1 helps researchers understand safety, dose, and tolerability, while Phase 2 looks for signs that the treatment is working against cancer.
The status is listed as Authorised, which means the study has approval to proceed according to the source data.
Key terms explained
dMMR means deficient mismatch repair, a problem in the cell’s DNA repair system. MSI-H means microsatellite instability-high, which is another way of describing a tumor with many DNA changes from poor repair.
RECIST 1.1 is a standard set of rules used to measure tumor response in cancer trials. A complete response means no signs of the tumor are found, and a partial response means the tumor has shrunk enough to count as a response under the study rules.
Serious adverse events are harmful medical events that are severe enough to matter a lot in a study, while other adverse events are side effects of any level of severity. Tolerability means how well participants can stay on treatment without major problems.