Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-31 @ 1:15 PM
Study NCT ID:
NCT06960395
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Vir Biotechnology, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: