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NCT06960395 · ClinicalTrials.gov registry record · Phase 1
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study of Solid Tumor Malignancies and EGFR, sponsored by Vir Biotechnology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 450
- Enrollment target
- 4
- Study locations
NCT06960395: Recruiting Phase 1 study of Solid Tumor Malignancies and EGFR, sponsored by Vir Biotechnology.
NCT06960395 is a Phase 1 study of Solid Tumor Malignancies and EGFR that is actively recruiting participants, run by Vir Biotechnology. The registered enrollment target is 450 participants, above the 155-participant average among 11 other Solid Tumor Malignancies trials with a reported enrollment target (190% higher). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06960395, a Phase 1 study of Solid Tumor Malignancies and EGFR, is actively recruiting participants, sponsored by Vir Biotechnology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 450 participants
- Enrollment target
- 4
- Study locations
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
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG VIR-5525
Study Locations (4)
Arizona
- Honor Health Research Institute - Scottsdale
Texas
- MD Anderson - Houston
New South Wales
- Wollongong Hospital - Wollongong
Queensland
- Princess Alexandra Hospital - Woolloongabba
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2029-08 |
| Phase | Phase 1 |
What NCT06960395 shows while recruiting
NCT06960395 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 155-participant average among 11 other Solid Tumor Malignancies trials with a reported enrollment target (190% higher).
The record links to 3 conditions, with Solid Tumor Malignancies appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06960395 reports a single indexed study location in Arizona, Texas, New South Wales.
Frequently Asked Questions
What is clinical trial NCT06960395 about?
NCT06960395 is a clinical study titled "Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors". 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 wil...
What is the current status of trial NCT06960395?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 450 participants. The study started on 2025-07-22. Estimated completion is 2029-08.
What conditions does trial NCT06960395 study?
This clinical trial studies the following conditions: Solid Tumor Malignancies, EGFR, EGFR Positive Solid Tumors.
What interventions are being tested in trial NCT06960395?
The interventions under investigation include: Pembrolizumab (DRUG), VIR-5525 (DRUG).
Who is sponsoring clinical trial NCT06960395?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06960395 being conducted?
This trial has 4 study locations across Arizona, Texas, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor Malignancies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06960395's enrollment target sits among peer trials
450 2nd of 11 the highest of 11 other Solid Tumor Malignancies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor Malignancies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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