To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Part of paid clinical trials in Duarte, California.

Sponsor
Vir Biotechnology, Inc.
Study ID
NCT05356741
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic HER2-Expressing Cancers

Eligibility Criteria

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

Interventions

  • VIR-5818 — DRUG
    Administered as IV infusion
  • pembrolizumab — DRUG
    Administered as IV infusion

Study Details

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: * Part 1 (dose escalation): Single-agent VIR-5818 * Part 2 (dose escalation): VIR-5818 plus pembrolizumab * Part 3 (dose expansion): Single-agent VIR-5818 * Part 4 (dose expansion): VIR-5818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 72 months.

Key Dates

First listed
May 2, 2022
Start date
Apr 13, 2022
Status verified
Aug 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Part 1 (dose escalation)
    Participants will receive single-agent VIR-5818
  • Experimental: Part 2 (dose escalation)
    Participants will receive VIR-5818 plus pembrolizumab
  • Experimental: Part 3 (dose expansion)
    Participants will receive single-agent VIR-5818
  • Experimental: Part 4 (dose expansion
    Participants will receive VIR-5818 plus pembrolizumab

Primary Outcome Measure

Incidence of dose-limiting toxicity - Part 1 and Part 2 [ Time Frame: Up to approximately 21 days (Part 1) and 42 days (Part 2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-

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City of Hope National Medical Center· Duarte, CA