RecruitingPhase 1Phase 2NCT07213609

A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

A Phase 1/2 Open-label, Multicenter Study of Oral GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors


Sponsor

GlaxoSmithKline

Enrollment

47 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK5460025 alone or in combination (potential combinations may be included in future amendments to the protocol) with other anti-cancer agents can decrease tumor size, is safe, well-tolerated, and how the drug is processed in the body over time.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called GSK5460025, alone or in combination with other cancer treatments, for people with advanced solid tumors that have a specific feature called mismatch repair deficiency (dMMR) or microsatellite instability (MSI-H). These features mean the cancer has trouble repairing its own DNA. **You may be eligible if...** - You have advanced (unresectable or metastatic) solid tumor cancer — including colorectal or endometrial cancer - Your tumor has dMMR/MSI-H status, or this can be tested - You have tried all available standard treatments (for Part 1), or have received 1–3 prior treatments including at least one immunotherapy (for Part 2) - You are reasonably functional (ECOG 0–2) with at least 3 months life expectancy - Your organs are functioning adequately **You may NOT be eligible if...** - You have untreated or progressing brain metastases - You have not recovered from side effects of prior cancer treatments - You have previously received a Werner helicase inhibitor or similar experimental drug - You have significant liver disease, uncontrolled gastrointestinal problems, or difficulty swallowing pills Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGSK5460025

GSK5460025 will be administered


Locations(9)

GSK Investigational Site

Canton, Ohio, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Hamilton, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT07213609


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