[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466669":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":11,"studyPopulation":11,"armGroups":56,"interventions":74,"overallOfficials":11,"centralContacts":85,"locations":91,"responsibleParty":187,"collaborators":189,"id":192,"slug":11,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":11,"eligibilityCriteria":197,"healthyVolunteers":198,"sex":199,"minAge":200,"maxAge":11,"enrollmentInfo":201,"targetDuration":11,"studyType":204,"phases":205,"briefSummary":208,"conditions":209,"keywords":11,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Vir Biotechnology, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Incidence of dose-limiting toxicity - Part 1 and Part 2",null,"Up to approximately 21 days (Part 1) and 42 days (Part 2)",{"measure":14,"description":11,"timeFrame":15},"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",{"measure":17,"description":18,"timeFrame":15},"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.",{"measure":20,"description":21,"timeFrame":15},"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.",[23,26,29,32,34,36,38,40,42,44,47],{"measure":24,"description":25,"timeFrame":15},"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).",{"measure":27,"description":28,"timeFrame":15},"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 iRECIST.",{"measure":30,"description":11,"timeFrame":31},"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",{"measure":33,"description":11,"timeFrame":31},"PK parameter: Maximum plasma concentration (Cmax)",{"measure":35,"description":11,"timeFrame":31},"PK parameter: Minimum serum concentration (Cmin)",{"measure":37,"description":11,"timeFrame":31},"PK parameter: Clearance (CL)",{"measure":39,"description":11,"timeFrame":31},"PK parameter: Volume of distribution at steady-state (Vss)",{"measure":41,"description":11,"timeFrame":31},"PK parameter: Accumulation ratio",{"measure":43,"description":11,"timeFrame":31},"PK parameter: Half-life (t1\u002F2)",{"measure":45,"description":11,"timeFrame":46},"Incidence of anti-drug antibodies (ADAs) to VIR-5818","Multiple timepoints at specified cycles (1 Cycle = 21 days) up to approximately 55 months",{"measure":48,"description":49,"timeFrame":15},"All parts: Disease control rate (DCR)","defined as CR+PR+ Stable Disease (SD) per RECIST v 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infusion",[58,64,69,72],{"type":76,"name":81,"description":78,"armGroupLabels":82,"otherNames":83},"pembrolizumab",[64,72],[84],"KEYTRUDA®",[86],{"name":87,"role":88,"phone":89,"phoneExt":11,"email":90},"Study Inquiry","CONTACT","415-654-5281","clinicaltrials@vir.bio",[92,106,115,126,137,148,154,163,169,178],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":11},"Investigational site number #100","RECRUITING","Melbourne","Victoria","3000","Australia","AU",{"type":101,"coordinates":102},"Point",[103,104],144.96332,-37.814,{"lat":104,"lon":103},{"facility":107,"status":94,"city":108,"state":11,"zip":109,"country":98,"countryCode":99,"cosmosGeoPoint":110,"geoPoint":114,"contacts":11},"Investigational site number #101","Randwick","2031",{"type":101,"coordinates":111},[112,113],151.24895,-33.91439,{"lat":113,"lon":112},{"facility":116,"status":94,"city":117,"state":11,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":11},"Investigational site number #150","Toulouse","31059","France","FR",{"type":101,"coordinates":122},[123,124],1.44367,43.60426,{"lat":124,"lon":123},{"facility":127,"status":94,"city":128,"state":11,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":11},"Investigational site number #200","Porto","4200-072","Portugal","PT",{"type":101,"coordinates":133},[134,135],-8.61097,41.1485,{"lat":135,"lon":134},{"facility":138,"status":94,"city":139,"state":11,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":11},"Investigational site number #255","Barcelona","08023","Spain","ES",{"type":101,"coordinates":144},[145,146],2.15899,41.38879,{"lat":146,"lon":145},{"facility":149,"status":94,"city":139,"state":11,"zip":150,"country":141,"countryCode":142,"cosmosGeoPoint":151,"geoPoint":153,"contacts":11},"Investigational site number #251","08035",{"type":101,"coordinates":152},[145,146],{"lat":146,"lon":145},{"facility":155,"status":94,"city":156,"state":11,"zip":157,"country":141,"countryCode":142,"cosmosGeoPoint":158,"geoPoint":162,"contacts":11},"Investigational site number #254","Madrid","28027",{"type":101,"coordinates":159},[160,161],-3.70256,40.4165,{"lat":161,"lon":160},{"facility":164,"status":94,"city":156,"state":11,"zip":165,"country":141,"countryCode":142,"cosmosGeoPoint":166,"geoPoint":168,"contacts":11},"Investigational site number #252","28050",{"type":101,"coordinates":167},[160,161],{"lat":161,"lon":160},{"facility":170,"status":94,"city":171,"state":11,"zip":172,"country":141,"countryCode":142,"cosmosGeoPoint":173,"geoPoint":177,"contacts":11},"Investigational site number #250","Pamplona","31008",{"type":101,"coordinates":174},[175,176],-1.64323,42.81687,{"lat":176,"lon":175},{"facility":179,"status":94,"city":180,"state":11,"zip":181,"country":141,"countryCode":142,"cosmosGeoPoint":182,"geoPoint":186,"contacts":11},"Investigational site number #253","Pozuelo de Alarcón","28223",{"type":101,"coordinates":183},[184,185],-3.81338,40.43293,{"lat":185,"lon":184},{"type":188,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[190],{"name":191,"class":6},"Merck Sharp & Dohme LLC","100466669",false,"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","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","Inclusion criteria:\n\n* Written informed consent by the participant (or legally acceptable representative if applicable)\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests\n\nExclusion criteria:\n\n* Significant cardiopulmonary disease and recent cardiac events\n* History of major organ autoimmune diseases\n* Acute or chronic infections\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",true,"ALL","18 Years",{"count":202,"type":203},645,"ESTIMATED","INTERVENTIONAL",[206,207],"PHASE1","PHASE2","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:\n\n* Part 1 (dose escalation): Single-agent VIR-5818\n* Part 2 (dose escalation): VIR-5818 plus pembrolizumab\n* Part 3 (dose expansion): Single-agent VIR-5818\n* Part 4 (dose expansion): VIR-5818 plus pembrolizumab\n\nThe total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.",[210],"Locally Advanced or Metastatic HER2-Expressing Cancers","2025-09-19",{"date":213,"type":214},"2025-09-24","ACTUAL",{"date":216,"type":214},"2022-04-13",{"date":218,"type":203},"2027-08-16",{"name":5,"class":6},10]