GSK5460025 alone or with other anti-cancer drugs for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2, early-stage interventional trial testing GSK5460025 as a single agent and in combination with other anti-cancer therapies to characterize safety, tolerability, preliminary anti-tumor activity, and how the drug is processed in the body. Participants must have advanced (unresectable, metastatic, or recurrent) solid tumors and either known dMMR/MSI-H status or provide tissue for central MMR/MSI testing. The study requires archival or fresh tumor samples, an ECOG performance status of 0–2, adequate organ function, and an expectation of at least three months' life expectancy. Dose-escalation and expansion cohorts are used to identify tolerable doses and to observe early signals of tumor shrinkage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Part 1 inclusion criteria:

• Has histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor and has exhausted all standard of care treatment options

Part 2 inclusion criteria:

* 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 Criteria:

* 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

Where it's running

• GSK Investigational Site
  Aurora, Colorado, United States Recruiting
• GSK Investigational Site
  Detroit, Michigan, United States Recruiting
• GSK Investigational Site
  Canton, Ohio, United States Recruiting
• GSK Investigational Site
  Nashville, Tennessee, United States Recruiting
• GSK Investigational Site
  Hamilton, Ontario, Canada Recruiting
• GSK Investigational Site
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.