drugset
drugset / Trial / NCT06960395

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

NCT06960395 ↗

Phase 1 Recruiting 450 enrolled Vir Biotechnology, Inc.
Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2025-07-22
Primary completion
2029-08
Completion
2029-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody — Intravenous
Subject VIR-5525 Unknown — Intravenous

Indications

No indication recorded.