> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/to-access-the-safety-and-effects-of-intravenous-475be808-115d-4eba-8f10-012c6a8eb0a3 > Record changed: 2026-10-13 # 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 NCT05356741 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) Participants 645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) Lead sponsor Vir Biotechnology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) Start date 2022-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) Number of sites 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Title and summary **Summary** 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 72 months. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Dates **Completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **First posted** 2022-05-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Primary completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Start date** 2022-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Size and sites **Participants** 645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Planned participants** 645 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Number of sites** 12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Lead sponsor** Vir Biotechnology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Identifiers **Registry ID** NCT05356741 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **ClinicalTrials.gov ID** NCT05356741 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Outcomes ### Primary outcomes 1. Incidence of dose-limiting toxicity - Part 1 and Part 2 Timeframe: Up to approximately 21 days (Part 1) and 42 days (Part 2) 2. Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)- Parts 1, 2, 3, and 4 Timeframe: Up to approximately 55 months 3. Objective Response Rate (ORR) - Part 3 and Part 4 Timeframe: 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. 4. Duration of Response (DOR) - Part 3 and Part 4 Timeframe: 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 1. ORR - Part 3 and Part 4 Timeframe: 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). 2. DOR - Part 3 and Part 4 Timeframe: 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. 3. Pharmacokinetics (PK) parameter: Area under the concentration-time curve (AUC) Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 4. PK parameter: Maximum plasma concentration (Cmax) Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 5. PK parameter: Minimum serum concentration (Cmin) Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 6. PK parameter: Clearance (CL) Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 7. PK parameter: Volume of distribution at steady-state (Vss) Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 8. PK parameter: Accumulation ratio Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 9. PK parameter: Half-life (t1/2) Timeframe: Predose, intermediate timepoints at multiple cycles (1 Cycle = 21 days) up to approximately 55 months 10. Incidence of anti-drug antibodies (ADAs) to VIR-5818 Timeframe: Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 55 months 11. All parts: Disease control rate (DCR) Timeframe: Up to approximately 55 months defined as CR+PR+ Stable Disease (SD) per RECIST v 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Sites - City of Hope National Medical CenterDuarte, United StatesRecruiting - Investigational site number #100Melbourne, AustraliaActive, not recruiting - Investigational site number #101Randwick, AustraliaRecruiting - Investigational site number #150Toulouse, FranceRecruiting - Investigational site number #200Porto, PortugalRecruiting - Investigational site number #257Madrid, SpainRecruiting - Investigational site number #255Barcelona, SpainRecruiting - Investigational site number #251Barcelona, SpainRecruiting - Investigational site number #254Madrid, SpainRecruiting - Investigational site number #252Madrid, SpainRecruiting - Investigational site number #250Pamplona, SpainRecruiting - Investigational site number #253Pozuelo de Alarcón, SpainRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## References ### Other registry identifiers - MK-3475-D14 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05356741) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Vir Biotechnology, Inc.](https://trialight.com/data/company/vir-biotechnology-inc-4e136db5-7823-4056-85d1-f1f37786d9c9.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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