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Study of GSK5460025 for Advanced Solid Tumors

This study is looking at a new drug, GSK5460025, for people with advanced solid tumors (abnormal lumps of tissue) that cannot be removed, have spread, or have come back. These tumors often have specific genetic features that can make them harder to treat. Researchers want to see if GSK5460025, given alone or with other anti-cancer drugs, is safe, well-tolerated, and can shrink tumors. They will also study how your body processes the drug. To join, you must be at least 18 years old and have a solid tumor with a known dMMR/MSI-H status (specific genetic markers) or have this status checked by the study team. The main goals are to track any side effects and how many people experience them.

Study design
This is an interventional study with a planned enrollment of 47 participants. The phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to approximately 33 months, with a specific observation period of up to 28 days for dose-limiting toxicities.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07213609

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
GlaxoSmithKline
~47 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:GSK5460025

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level
Measured over Up to 28 days
+4 more outcomes measured

Conditions

Neoplasms, Colorectal
Neoplasms

Explore related trials

Colorectal CarcinomaEndometrial CarcinomaSolid NeoplasmMRC1 wt AlleleMSI1 Gene

Where it's being run

22 sites across 11 states
Spain5
Japan4
Sweden3
Ontario2
Netherlands2
Colorado1
Michigan1
Ohio1

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor
Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) status at the time of Pre-screening and MMR/MSI status will be determined by central reference laboratory
Provides an archival or fresh (preferred) formalin fixed, paraffin embedded (FFPE) sample
Intends to receive GSK5460025 as next treatment
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Is expected to have a minimum of 3 months life expectancy
Has adequate organ function, as defined in the protocol
Has histologically diagnosed advanced (unresectable, metastatic or recurrent) Colorectal cancer (CRC) or Endometrial cancer (EC)
Has received at least 1 but no more than 3 lines of systemic anticancer therapy for their advanced (unresectable, metastatic or recurrent) disease including at least one line of Immune checkpoint inhibitors (ICI) therapy
Has measurable disease (i.e., at least 1 target lesion) during the Screening period per RECIST 1.1, as determined by the investigator

Exclusion

Has not recovered (i.e., to Grade ≤1 or to baseline) from prior anticancer therapy-induced Adverse Events (AEs)
Has received prior treatment with a Werner (WRN) inhibitor or Nucleotide Excision Repair Targeting (NERT) agent.
Is unable to swallow and retain orally administered study treatment
Has untreated or progressed metastases in brain or CNS
Has a known additional malignancy that progressed or required active treatment within the last 2 years because reoccurrence of another malignancy would confound interpretation by RECIST 1.1 criteria. Exceptions include basal or squamous cell carcinomas of the skin or in situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
Has any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs
Has cirrhosis or current unstable liver or biliary disease
Has known hypersensitivity to any of the study interventions or any of their excipients

What this trial measures

  • Part 1: Number of participants with dose limiting toxicities (DLTs) per dose levelUp to 28 days
  • Part 1: Number of participants with treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events (TEAEs) by severity per dose levelUp to approximately 33 months
  • Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation periodUp to 28 days
  • Part 1: Number of participants with dosage modifications due to TEAEs per dose levelUp to approximately 33 months
  • Part 2: Objective Response Rate (ORR)Up to approximately 33 months

    ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by investigator assessment.