VIR-5818
DrugAdministered as IV infusion
Recruiting
NCT Number: 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
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:
* Part 1 (dose escalation): Single-agent VIR-5818 * Part 2 (dose escalation): VIR-5818 plus pembrolizumab * Part 3 (dose expansion): Single-agent VIR-5818 * Part 4 (dose expansion): VIR-5818 plus pembrolizumab
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Investigational site number #100, Melbourne, Victoria, Australia
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 growth factor receptor 2 (HER2) status, per local tests
Exclusion criteria
- Significant cardiopulmonary disease and recent cardiac events
- History of major organ autoimmune diseases
- Acute or chronic infections
The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Treatment and study plan
Pembrolizumab
DrugAdministered as IV infusion
Other names: KEYTRUDA®
Primary outcomes
-
Incidence of dose-limiting toxicity - Part 1 and Part 2
Time frame: 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
Time frame: Up to approximately 55 months
-
Objective Response Rate (ORR) - Part 3 and Part 4
Time frame: Up to approximately 55 months
ORR defined as a Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
-
Duration of Response (DOR) - Part 3 and Part 4
Time frame: Up to approximately 55 months
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.
Secondary outcomes
-
ORR - Part 3 and Part 4
Time frame: Up to approximately 55 months
ORR defined as defined as a Complete Response (CR) or Partial Response (PR) per Immune Response Evaluation Criteria in Solid Tumors (iRECIST).
-
DOR - Part 3 and Part 4
Time frame: Up to approximately 55 months
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.
-
Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC)
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
PK parameter: Maximum plasma concentration (Cmax)
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
PK parameter: Minimum serum concentration (Cmin)
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
PK parameter: Clearance (CL)
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
PK parameter: Volume of distribution at steady-state (Vss)
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
PK parameter: Accumulation ratio
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
PK parameter: Half-life (t1/2)
Time frame: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months
-
Incidence of anti-drug antibodies (ADAs) to VIR-5818
Time frame: Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 55 months
-
All parts: Disease control rate (DCR)
Time frame: Up to approximately 55 months
defined as CR+PR+ Stable Disease (SD) per RECIST v 1.1
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Vir Biotechnology, Inc.
Industry
Collaborators
- Merck Sharp & Dohme LLC
Registry information
Official study title
A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
Important dates
- Study start
- 2022
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- May 2, 2022
- Registry last updated
- Sep 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.