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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Vir Biotechnology, Inc.
Study ID
NCT06960395
Phase
PHASE1
Status
Recruiting
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Conditions

  • EGFR
  • EGFR Positive Solid Tumors
  • Solid Tumor Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VIR-5525 — DRUG
    Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion
  • Pembrolizumab — DRUG
    Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion

Study Details

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

Key Dates

Start date
Jul 22, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: VIR-5525 Monotherapy Dose Escalation
    Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy.
  • Experimental: Part 2: VIR-5525 Monotherapy Dose Expansion
    Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy.
  • Experimental: Part 3: VIR-5525 Combination Dose Escalation
    Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab.
  • Experimental: Part 4: VIR-5525 Combination Dose Expansion
    Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Honor Health Research InstituteScottsdaleArizona85258-4566-
MD AndersonHoustonTexas77030-

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By research site
Honor Health Research Institute· Scottsdale, AZMD Anderson· Houston, TX

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