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

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

NCT Number	NCT06960395
Lead Sponsor	Vir Biotechnology, Inc.
Conditions	Solid Tumor Malignancies, EGFR Positive Solid Tumors, EGFR
Enrollment	450 participants
Start Date	2025-07-22
Primary Completion	2029-08 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-04-13