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

NCT06960395 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-04-13

No results posted yet for this study

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

  • EGFR Positive Solid Tumors
  • EGFR
  • Solid Tumor Malignancies

Interventions

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

Sponsors & Collaborators

  • Vir Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Vir Biotechnology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960395 on ClinicalTrials.gov