NCT06960395

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

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: Phase 1
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Vir Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Solid Tumor Malignancies
• EGFR Positive Solid Tumors
• EGFR

Interventions

Type	Name	Description
DRUG	VIR-5525	Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
DRUG	Pembrolizumab	Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion

Timeline

• Start date: 2025-07-22
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2025-05-07
• Last updated: 2026-04-13

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study