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A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP Inhibitor (PARPi) Niraparib in Adult Participants With Solid Tumors

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Trial Profile

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP Inhibitor (PARPi) Niraparib in Adult Participants With Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs IDE 705 (Primary) ; Niraparib (Primary)
  • Indications Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors GSK

Most Recent Events

  • 04 Jun 2025 Planned End Date changed from 9 Nov 2029 to 29 Jun 2027.
  • 04 Jun 2025 Planned primary completion date changed from 30 Dec 2027 to 29 Jun 2027.
  • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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