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Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Site details revised at 1 of 4 sitesv6
  2. Study sites: 3 to 4v5
  3. Start date changed from estimate of Jul 2025 to Jul 22, 2025v4
  4. Start date: May 2025 to Jul 2025
    • Site details revised at 2 of 3 sites
    • Eligibility criteria expanded, about 3 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR. The study will be conducted in the following 4 parts: * Part 1: VIR-5525 monotherapy dose escalation * Part 2: VIR-5525 monotherapy dose expansion * Part 3: VIR-5525 plus pembrolizumab dose escalation * Part 4: VIR-5525 plus pembrolizumab dose expansion
Trial Details
NCT Number NCT06960395
Lead Sponsor Vir Biotechnology, Inc.
Conditions
(from sponsor)		 Solid Tumor Malignancies, EGFR Positive Solid Tumors, EGFR
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov