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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GSK5460025

Treatment groups

47 Participants
are divided into 2 treatment groups

Sponsors and collaborators