[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-her2-expressing-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-her2-expressing-cancers":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},645,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27],"Locally Advanced or Metastatic HER2-Expressing Cancers","RECRUITING","2025-09-19",{"date":31,"type":32},"2025-09-24","ACTUAL",{"date":34,"type":32},"2022-04-13",{"date":36,"type":20},"2027-08-16",{"name":38,"class":39},"Vir Biotechnology, Inc.","INDUSTRY",10,""]