Clareo Health | 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 Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
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) solid tumor and has exhausted all standard of care treatment options
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
You may not be if
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
