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Study of VIR-5525 with or without Pembrolizumab for Solid Tumors

This study is testing a new drug called VIR-5525, both alone and in combination with pembrolizumab, for people with locally advanced or metastatic (spread to other parts of the body) solid tumors. To join, your tumor must have a specific biomarker called EGFR. Researchers want to see how safe VIR-5525 is and if it shows early signs of shrinking tumors. The study is open to adults aged 18 or older who have a good general health status and a life expectancy of at least 12 weeks. The study plans to enroll 450 participants, but its current status is unclear.

Study design
This is a Phase 1, first-in-human study with 450 planned participants. It involves increasing doses of VIR-5525 alone, then increasing doses of VIR-5525 with pembrolizumab, followed by expansion phases for both.
What's involved
Safety and efficacy will be measured from Cycle 1, Day 1 (each cycle is 21 days) for up to approximately 52 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and efficacy for up to approximately 52 months after starting treatment.

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NCT06960395

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Vir Biotechnology, Inc.
~450 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:VIR-5525Pembrolizumab

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Objectives (Parts 1 and 3)
Measured over From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.
+2 more outcomes measured

Conditions

Solid Tumor Malignancies
EGFR Positive Solid Tumors
EGFR

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Where it's being run

4 sites across 4 states
Arizona1
Texas1
New South Wales1
Queensland1

Study leadership

  • Clinical Sciences & Operations · STUDY_DIRECTOR · Vir Biotechnology

Who to contact

Study Inquiry
[email protected]
1-415-654-5281
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)
Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency
History of hepatitis B infection (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV \[HCV RNA; qualitative\] is detected)
History of HIV infection. No HIV testing is required unless mandated by the local health authority.
Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1
Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor)

What this trial measures

  • Primary Safety Objectives (Parts 1 and 3)From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.

    Objective: To evaluate the safety and tolerability of escalating doses of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3). Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.

  • Primary Safety Objectives (Parts 1 and 3)From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.

    Objective: To determine the recommended dose(s) for expansion cohorts of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3). Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.

  • Primary Efficacy Objectives (Parts 2 and 4)From Cycle 1, Day 1 (each cycle is 21 days), up to approximately 52 months.

    Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts. Endpoint: Objective response, defined as a CR or PR per RECIST v1.1.