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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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 16, 2027 → Apr 2028
See other at-risk trials from Vir Biotechnology, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 16, 2027 to Apr 2028
    • Study sites: 10 to 12
    v17
  2. Re-verified, no change to tracked fieldsv16
  3. Interventions: AMX-818 (Drug), pembrolizumab (Drug) to VIR-5818 (Drug), pembrolizumab (Drug)
    • Secondary endpoints revised (11)
    • Study title revised
    v15
  4. Lead sponsor: Amunix, a Sanofi Company to Vir Biotechnology, Inc.v14
  5. Primary completion date: Dec 9, 2026 to Aug 16, 2027
    • Site details revised at 1 of 10 sites
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Enrollment target: 575 to 645
    • Study completion date: Dec 9, 2026 to Aug 16, 2027
    • Start date: Apr 27, 2022 to Apr 13, 2022
    • Secondary endpoints: 10 to 11
    v12
  2. Phase: Phase 1 to Phase 1/2
    • Interventions: AMX-818 (Drug), Pembrolizumab (Drug) to AMX-818 (Drug), pembrolizumab (Drug)
    • Collaborators expanded, about 5 words
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Secondary endpoints: details revised at 1 of 10 entriesv9
  5. Study sites: 9 to 10v8
  6. Study sites: 8 to 9
    • Interventions: AMX 818 (Drug), Pembrolizumab (Drug) to AMX-818 (Drug), Pembrolizumab (Drug)
    • Secondary endpoints revised (10)
    • Study title shortened, about 1 word
    v7
  7. Enrollment target: 560 to 575
    • Study sites: 7 to 8
    v6
  8. Study sites: 6 to 7v5
  9. Re-verified, no change to tracked fieldsv4
  10. Study sites: 2 to 6v3
  11. Start date changed from estimate of Apr 2022 to Apr 27, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05356741
Lead Sponsor Vir Biotechnology, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Locally Advanced or Metastatic HER2-Expressing Cancers
Enrollment 645 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov