Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VIR-5818 · 1 trial · 1 indication
ORR defined as a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1 (dose escalation) | EXPERIMENTAL | Participants will receive single-agent VIR-5818 |
| Part 2 (dose escalation) | EXPERIMENTAL | Participants will receive VIR-5818 plus pembrolizumab |
| Part 3 (dose expansion) | EXPERIMENTAL | Participants will receive single-agent VIR-5818 |
| Part 4 (dose expansion | EXPERIMENTAL | Participants will receive VIR-5818 plus pembrolizumab |
| Name | Type | Description |
|---|---|---|
| VIR-5818 | DRUG | Administered as IV infusion |
| pembrolizumab | DRUG | Administered as IV infusion |
Inclusion criteria: * Written informed consent by the participant (or legally acceptable representative if applicable) * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Diseases under study, prior lines of therapy, and human epidermal ...
VIR-5818 is being studied for the treatment of locally advanced or metastatic HER2-expressing cancers. It is an investigational therapy in Phase 1 clinical development and has not been approved for any indication. The trial enrolls adults with these advanced HER2-expressing tumors.
VIR-5818 targets HER2, a protein expressed on the surface of certain cancer cells. It is a small molecule designed to bind HER2. The Phase 1 study enrolls patients whose locally advanced or metastatic cancers express HER2, making it a biomarker-selected population.
VIR-5818 is being developed by Vir Biotechnology, Inc., which trades on the Nasdaq under the ticker VIR. The company is running the Phase 1 study of the small molecule in patients with locally advanced or metastatic HER2-expressing cancers.
VIR-5818 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The single Phase 1 trial is currently recruiting participants across the United States, Australia, France, Portugal, and Spain.
VIR-5818 is being evaluated in one clinical trial, NCT05356741, titled a study of intravenous VIR-5818 alone and in combination with pembrolizumab in adults with locally advanced or metastatic HER2-expressing cancers. The Phase 1 trial is recruiting, with an estimated enrollment of 645 participants and sites in five countries.