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
GlaxoSmithKline
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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) perfo…
Interventions
- DrugGSK5460025
GSK5460025 will be administered
Locations (9)
- GSK Investigational SiteCanton, Ohio
- GSK Investigational SiteNashville, Tennessee
- GSK Investigational SiteHamilton, Ontario
- GSK Investigational SiteToronto, Ontario
- GSK Investigational SiteMontreal, Quebec
- GSK Investigational SiteChiba