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
← catalyst calendarNCT05356741 · readout ≤ 620 d
Sponsored by Vir Biotechnology, Inc. (industry) · VIR — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
645estimated
Sites
12
Countries
Australia, France, Portugal +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-04-13 | actual | When the study began enrolling |
| Primary completion | Apr 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Locally Advanced or Metastatic HER2-Expressing Cancers
Interventions
- Drug: VIR-5818
- Drug: pembrolizumab — also filed as KEYTRUDA®
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose-limiting toxicity - Part 1 and Part 2
measured 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
measured Up to approximately 55 months
Objective Response Rate (ORR) - Part 3 and Part 4
measured Up to approximately 55 months
Duration of Response (DOR) - Part 3 and Part 4
measured Up to approximately 55 months
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