[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519683":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":24,"locations":29,"responsibleParty":62,"collaborators":20,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":20,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":20,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Guangzhou Virotech Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"M1-c6v1 intravenous injection","EXPERIMENTAL","M1-c6v1 will be administered through IV drip",[13],"Biological: M1-c6v1",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","M1-c6v1","Intravenous drip administration",[9],null,[22],{"name":5,"affiliation":5,"role":23},"STUDY_CHAIR",[25],{"name":5,"role":26,"phone":27,"phoneExt":20,"email":28},"CONTACT","+86-020-32030725","clinicaltrialinfo@virot.cn",[30,41,55],{"facility":31,"status":32,"city":33,"state":34,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":20,"geoPoint":20,"contacts":37},"National Cancer Center Hospital East","RECRUITING","Kashiwa-shi","Chiba","Japan","JP",[38],{"name":39,"role":26,"phone":40,"phoneExt":20,"email":28},"Dr. Kojima Takashi, M.D.","+81-4-7133-1111",{"facility":42,"status":32,"city":43,"state":44,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"National Hospital Organization Shikoku Cancer Center","Matsuyama","Ehime",{"type":46,"coordinates":47},"Point",[48,49],132.76574,33.83916,{"lat":49,"lon":48},[52],{"name":53,"role":26,"phone":54,"phoneExt":20,"email":28},"Dr. Nishina Tomohiro, M.D.","+81-89-999-1111",{"facility":56,"status":32,"city":57,"state":58,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":20,"geoPoint":20,"contacts":59},"St. Marianna University Hospital","Kawasaki-shi","Kanagawa",[60],{"name":61,"role":26,"phone":20,"phoneExt":20,"email":28},"Dr. Sunakawa, Yu, M.D.",{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100519683","phase-1-a-study-of-intravenous-m1-c6v1-for-locally-advanced-or-metastatic-solid-tumors-100519683",false,"NCT06046742","A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors","A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients with Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.\n2. Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.\n3. Males and females at least 18 years of age, inclusive, at the Screening Visit.\n4. Have at least one measurable lesion.\n5. An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.\n6. An estimated survival time of ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.\n2. Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.\n3. Subject has received systemic glucocorticoids (prednisone \\>10 mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.\n4. Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.","ALL","18 Years",{"count":74,"type":75},12,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors",[81],"Solid Tumor",[17,81,83,84],"Oncolytic Virus","VRT106","2025-03-10",{"date":87,"type":88},"2025-03-13","ACTUAL",{"date":90,"type":88},"2024-07-10",{"date":92,"type":75},"2026-12-20",{"name":5,"class":6},3]