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

Condition(s) studied

Investigational drug(s) / intervention(s)

VIR-5818: Administered as IV infusion

pembrolizumab: Administered as IV infusion

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence of dose-limiting toxicity - Part 1 and Part 2 — Up to approximately 21 days (Part 1) and 42 days (Part 2)
• Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4 — Up to approximately 55 months
• Objective Response Rate (ORR) - Part 3 and Part 4 — Up to approximately 55 months
  ORR defined as a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
• Duration of Response (DOR) - Part 3 and Part 4 — Up to approximately 55 months
  DOR defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST v.1.1.

Trial sites (12)

On this site

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