[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100466669","phase-1-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-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":20,"type":21},645,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Locally Advanced or Metastatic HER2-Expressing Cancers","RECRUITING","2025-09-19",{"date":32,"type":33},"2025-09-24","ACTUAL",{"date":35,"type":33},"2022-04-13",{"date":37,"type":21},"2027-08-16",{"name":39,"class":40},"Vir Biotechnology, Inc.","INDUSTRY",10]