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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-D14 | Other Identifier | Merck Sharp & Dohme LLC | |
| KEYNOTE-D14 | Other Identifier | Merck Sharp & Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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:
The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (dose escalation) | Experimental | Participants will receive single-agent VIR-5818 |
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| Part 2 (dose escalation) | Experimental | Participants will receive VIR-5818 plus pembrolizumab |
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| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-5818 | Drug | Administered as IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ORR defined as a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. | Up to approximately 55 months |
| Duration of Response (DOR) - Part 3 and Part 4 | 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. | Up to approximately 55 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR - Part 3 and Part 4 | ORR defined as defined as a Complete Response (CR) or Partial Response (PR) per Immune Response Evaluation Criteria in Solid Tumors (iRECIST). | Up to approximately 55 months |
| DOR - Part 3 and Part 4 |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Contact | 415-654-5281 | clinicaltrials@vir.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site number #100 | Recruiting | Melbourne | Victoria | 3000 | Australia | |
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| pembrolizumab | Drug | Administered as IV infusion |
|
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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 iRECIST.
| Up to approximately 55 months |
| Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC) | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| PK parameter: Maximum plasma concentration (Cmax) | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| PK parameter: Minimum serum concentration (Cmin) | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| PK parameter: Clearance (CL) | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| PK parameter: Volume of distribution at steady-state (Vss) | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| PK parameter: Accumulation ratio | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| PK parameter: Half-life (t1/2) | Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months |
| Incidence of anti-drug antibodies (ADAs) to VIR-5818 | Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 55 months |
| All parts: Disease control rate (DCR) | defined as CR+PR+ Stable Disease (SD) per RECIST v 1.1 | Up to approximately 55 months |
| Investigational site number #101 |
| Recruiting |
| Randwick |
| 2031 |
| Australia |
| Investigational site number #150 | Recruiting | Toulouse | 31059 | France |
| Investigational site number #200 | Recruiting | Porto | 4200-072 | Portugal |
| Investigational site number #255 | Recruiting | Barcelona | 08023 | Spain |
| Investigational site number #251 | Recruiting | Barcelona | 08035 | Spain |
| Investigational site number #254 | Recruiting | Madrid | 28027 | Spain |
| Investigational site number #252 | Recruiting | Madrid | 28050 | Spain |
| Investigational site number #250 | Recruiting | Pamplona | 31008 | Spain |
| Investigational site number #253 | Recruiting | Pozuelo de Alarcón | 28223 | Spain |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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