Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
GlaxoSmithKline (Voir sur ClinicalTrials)
octobre 2025
octobre 2028
25 septembre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 25/09/2026 14:50:03 | Contacter | ||
Critères
Tous
- 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