Actively Recruiting
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Led by Vir Biotechnology, Inc. · Updated on 2026-04-13
450
Participants Needed
4
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- ECOG performance status of 0 to 1
- Life expectancy of at least 12 weeks
- Histological, pathological, or cytological confirmation of unresectable, locally advanced, or metastatic disease
- Measurable disease per RECIST v1.1, including progressing lesions in previously irradiated areas
- Diagnosis of NSCLC (any histology), colorectal cancer, head and neck squamous cell carcinoma, or cutaneous squamous cell carcinoma (nasopharyngeal tumors allowed; upper esophageal and salivary gland tumors excluded)
- Or solid tumor with EGFR amplification confirmed by validated local assay
- No available standard systemic therapy, or standard therapy is intolerable, ineffective, inaccessible, or refused by participant
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test within 72 hours before treatment
- Acute or chronic infections including active Epstein-Barr virus, chronic active EBV disease, hepatitis B or C infection, HIV infection, or active infection needing systemic therapy within 14 days before treatment
- Known positive COVID-19 test at screening (except if followed by negative test and asymptomatic)
- Medical or inflammatory conditions increasing risk of toxicity to VIR-5525 or pembrolizumab
- QTcF interval greater than 480 ms
- Prior systemic anti-cancer therapy within 5 half-lives or 28 days before first study dose
- Prior radiotherapy within 2 weeks before study start unless recovered to Grade 1 or baseline without corticosteroids and no radiation pneumonitis (palliative radiation allowed with specified washout)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258-4566
Actively Recruiting
2
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
3
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
4
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
Research Team
S
Study Inquiry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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