Table of contents
- Trial overview
- Who can join the study
- What the study measures
- Study parts and treatment approach
- Trial phase and status
- Key terms explained
Trial overview
This study is a Phase 1/2 trial of GSK5460025A in people with dMMR/MSI-H solid tumors, including colorectal cancer.[1] The trial is designed to look first at safety and dose, then at early signs that the treatment may help shrink tumors.[1]
The study is interventional, which means participants receive a study treatment rather than only being observed.[1] The trial status is Authorised, and the planned enrollment is 47 participants.[1]
Who can join the study
The main target population is people with dMMR/MSI-H solid tumors.[1] 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.[1]
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.[1]
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.[1] It also measures treatment-emergent serious adverse events and other treatment-emergent adverse events, which are health problems that appear after treatment starts.[1]
Other safety measures include how long these side effects last and whether dose changes are needed because of side effects.[1] These outcomes help researchers decide the recommended dose for expansion and/or the maximum tolerated dose.[1]
The second part measures Objective Response Rate, or ORR, which is the percentage of participants with a confirmed complete response or partial response.[1] In simple terms, this shows how many tumors fully disappear or shrink enough to count as a response under the study rules.[1]
Study parts and treatment approach
Part 1 studies GSK5460025A as monotherapy, meaning it is given alone.[1] 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.[1]
Part 2 looks at early anti-tumor activity in colorectal cancer and, separately, endometrial cancer.[1] 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.[1]
Trial phase and status
This is a Phase 1/2 study, so it combines early safety testing with early effectiveness testing.[1] Phase 1 helps researchers understand safety, dose, and tolerability, while Phase 2 looks for signs that the treatment is working against cancer.[1]
The status is listed as Authorised, which means the study has approval to proceed according to the source data.[1]
Key terms explained
dMMR means deficient mismatch repair, a problem in the cell’s DNA repair system.[1] MSI-H means microsatellite instability-high, which is another way of describing a tumor with many DNA changes from poor repair.[1]
RECIST 1.1 is a standard set of rules used to measure tumor response in cancer trials.[1] 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.[1]
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.[1] Tolerability means how well participants can stay on treatment without major problems.[1]
