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 an investigational small molecule being developed for the treatment of locally advanced or metastatic HER2-expressing cancers. It is currently in Phase 1 clinical development and has not been approved by the FDA.
VIR-5818 targets HER2, a protein that is overexpressed in certain cancers. By targeting HER2, the drug aims to interfere with cancer cell growth and survival in patients with HER2-expressing tumors.
VIR-5818 is being developed by Vir Biotechnology, Inc., a company publicly traded under the ticker symbol VIR on the NASDAQ stock exchange.
VIR-5818 is in Phase 1 clinical development. It is being studied in an ongoing clinical trial that is currently recruiting participants, and it is not yet approved for commercial use.
VIR-5818 is being evaluated in a Phase 1 clinical trial with the identifier NCT05356741. The trial is assessing the safety and effects of VIR-5818 alone and in combination with pembrolizumab in adult participants with locally advanced or metastatic HER2-expressing cancers.
VIR-5818 is a distinct investigational drug and is not known to be the same as any other approved or marketed medication. It is being studied as a monotherapy and in combination with pembrolizumab in clinical trials.