Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05356741 | 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 | PHASE1 | RECRUITING | 645 | — | — | Apr 13, 2022 | Aug 16, 2027 | Sep 24, 2025 | 10 | Australia, France +2 |
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 ...