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A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

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Trial Profile

A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Aug 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; VIR 5525 (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Head and neck cancer; Non-small cell lung cancer; Skin cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Vir Biotechnology

Most Recent Events

  • 24 Jul 2025 According to a Vir Biotechnology media release, the company has announced that the First Patient was dosed in Phase 1 Clinical Trial of EGFR-Targeting PRO-XTEN™ Dual-Masked T-Cell Engager VIR-5525 for the Treatment of Solid Tumors. This triggered a $75 million milestone payment as part of the Company's 2024 exclusive worldwide license agreement with Sanofi for the PRO-XTEN™ platform and clinical-stage T-cell engagers.
  • 29 Jun 2025 Planned initiation date changed from 1 May 2025 to 1 Jul 2025.
  • 13 May 2025 Status changed from not yet recruiting to recruiting.

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