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A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 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 (SYLVER)

Trial Profile

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 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 (SYLVER)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs GSK 4418959 (Primary)
  • Indications Colon cancer; Colorectal cancer; Endometrial cancer; Rectal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms SYLVER
  • Sponsors GSK

Most Recent Events

  • 30 Apr 2025 Trial design presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 04 Feb 2025 Planned End Date changed from 29 Jun 2028 to 16 Jun 2028.
  • 04 Feb 2025 Planned primary completion date changed from 1 Mar 2027 to 16 Feb 2027.

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