[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600155":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":41,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":228,"collaborators":26,"id":230,"slug":26,"hasResults":231,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":26,"eligibilityCriteria":235,"healthyVolunteers":231,"sex":236,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":26,"studyType":242,"phases":243,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":127,"whyStopped":26,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":259},{"fullName":5,"class":6},"Guangzhou Virotech Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent\u002Fprogressive glioblastoma","To evaluate the safety and tolerability of VRT106 in patients with recurrent\u002Fprogressive glioblastoma and to explore the maximum tolerated dose (MTD)\u002Fmultiple ascending dose (MAD)\u002Foptimal biologically active dose (OBD) and\u002For the recommended phase 2 dose(RP2D), which will provide a recommended dose for subsequent clinical trials. The specific outcome indicator data that need to be evaluated and collected include: adverse event, physical examinations, vital signs, clinical laboratory tests (including blood routine, blood biochemistry.urine routine, coagulation function), Eastern Cooperative Oncology Group (ECOG) performance status, twelve-lead electrocardiogram(ECG) and concomitant medication assessments.","About 2 years",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Overall survival","Time from initial administration to death",{"measure":18,"description":19,"timeFrame":12},"Objective response rate","Objective response rate assessed according to the Neuro-Oncology Response Evaluation Criteria, complete response (CR) + partial response (PR)",{"measure":21,"description":22,"timeFrame":12},"Distribution and shedding of VRT106 virus","Concentration of VRT106 virus in blood",{"measure":24,"description":25,"timeFrame":12},"Overall survival rate","Overall survival rates at 6, 9 and 12 months",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","This study is an open-label, single-arm Phase I\u002FII clinical trial comprising two parts: Phase I and Phase II. Phase I is a dose-escalation phase, with the primary objective of assessing the safety and tolerability of VRT106 at escalating doses in subjects with recurrent\u002Fprogressive glioblastoma and confirming the Recommended Phase II Dose (RP2D). Phase II is a dose-expansion phase, in which subjects will receive VRT106 at the RP2D dose level, aiming to further evaluate the efficacy and safety of VRT106 in subjects with recurrent\u002Fprogressive glioblastoma.",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"VRT106","EXPERIMENTAL","VRT106 will be administered intravenously",[40],"Drug: VRT106",[42],{"type":43,"name":36,"description":44,"armGroupLabels":45,"otherNames":26},"DRUG","VRT106,intravenous",[36],[47],{"name":48,"affiliation":49,"role":50},"Chengcheng Guo","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[52,56],{"name":48,"role":53,"phone":54,"phoneExt":26,"email":55},"CONTACT","020-87343990","guochch@sysucc.org.cn",{"name":57,"role":53,"phone":58,"phoneExt":26,"email":59},"Ke Sai","020-87343890","saike@sysucc.org.cn",[61,80,95,110,125,138,152,168,182,199,214],{"facility":62,"status":63,"city":64,"state":65,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"The First Affiliated Hospital of USTC","NOT_YET_RECRUITING","Hefei","Anhui","China","CN",{"type":69,"coordinates":70},"Point",[71,72],117.28083,31.86389,{"lat":72,"lon":71},[75,78],{"name":26,"role":53,"phone":76,"phoneExt":26,"email":77},"0551-62282931","ahslyyllwyh@163.com",{"name":79,"role":50,"phone":26,"phoneExt":26,"email":26},"Chaoshi Niu, Professor",{"facility":81,"status":63,"city":82,"state":83,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Sanbo Brain Hospital Capital Medical University","Beijing","Beijing Municipality",{"type":69,"coordinates":85},[86,87],116.39723,39.9075,{"lat":87,"lon":86},[90,93],{"name":26,"role":53,"phone":91,"phoneExt":26,"email":92},"010-62856766","myzhou1001@126.com",{"name":94,"role":50,"phone":26,"phoneExt":26,"email":26},"Junping Zhang, Professor",{"facility":96,"status":63,"city":97,"state":98,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"The Cancer Hospital Affiliated to Chongqing University","Chongqing","Chongqing Municipality",{"type":69,"coordinates":100},[101,102],106.55771,29.56026,{"lat":102,"lon":101},[105,108],{"name":26,"role":53,"phone":106,"phoneExt":26,"email":107},"023-65075696","czll6545@126.com",{"name":109,"role":50,"phone":26,"phoneExt":26,"email":26},"Haifeng Yang, Professor",{"facility":111,"status":63,"city":112,"state":113,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Nanfang Hospital, Southern Medical University","Guangzhou","Guangdong",{"type":69,"coordinates":115},[116,117],113.25,23.11667,{"lat":117,"lon":116},[120,123],{"name":26,"role":53,"phone":121,"phoneExt":26,"email":122},"020-62787238","nfyyec@163.com",{"name":124,"role":50,"phone":26,"phoneExt":26,"email":26},"Songtao Qi, Professor",{"facility":126,"status":127,"city":112,"state":113,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":128,"geoPoint":130,"contacts":131},"Sun Yat-sen University Cancer Center","RECRUITING",{"type":69,"coordinates":129},[116,117],{"lat":117,"lon":116},[132,134,136],{"name":26,"role":53,"phone":54,"phoneExt":26,"email":133},"llwyh@sysucc.org.cn",{"name":135,"role":50,"phone":26,"phoneExt":26,"email":26},"Chengcheng Guo, Professor",{"name":137,"role":50,"phone":26,"phoneExt":26,"email":26},"Ke Sai, Professor",{"facility":139,"status":127,"city":140,"state":113,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Shenzhen Second People's Hospital","Shenzhen",{"type":69,"coordinates":142},[143,144],114.0683,22.54554,{"lat":144,"lon":143},[147,150],{"name":26,"role":53,"phone":148,"phoneExt":26,"email":149},"0755-83464301","lunli707@126.com",{"name":151,"role":50,"phone":26,"phoneExt":26,"email":26},"Fanfan Chen, Professor",{"facility":153,"status":127,"city":154,"state":113,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"The Fifth Affiliated Hospital of Sun Yat-sen University","Zhuhai",{"type":69,"coordinates":156},[157,158],113.56778,22.27694,{"lat":158,"lon":157},[161,164,166],{"name":26,"role":53,"phone":162,"phoneExt":26,"email":163},"0756-2528895","zdwyllwyh@163.com",{"name":165,"role":50,"phone":26,"phoneExt":26,"email":26},"Rui You, Professor",{"name":167,"role":50,"phone":26,"phoneExt":26,"email":26},"Fei Liu, Professor",{"facility":169,"status":127,"city":170,"state":171,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Guangxi Medical University Cancer Hospital","Nanning","Guangxi",{"type":69,"coordinates":173},[174,175],108.31667,22.81667,{"lat":175,"lon":174},[178,180],{"name":26,"role":53,"phone":179,"phoneExt":26,"email":26},"0771-5323064",{"name":181,"role":50,"phone":26,"phoneExt":26,"email":26},"Ligen Mo, Professor",{"facility":183,"status":63,"city":184,"state":185,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":69,"coordinates":187},[188,189],116.99722,36.66833,{"lat":189,"lon":188},[192,195,197],{"name":26,"role":53,"phone":193,"phoneExt":26,"email":194},"0531-82165413","qlyygcp_ec@qiluhospital.com",{"name":196,"role":50,"phone":26,"phoneExt":26,"email":26},"Gang Li, Professor",{"name":198,"role":50,"phone":26,"phoneExt":26,"email":26},"Hong Liu, Professor",{"facility":200,"status":63,"city":201,"state":202,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Tangdu Hospital of Air Force Medical University of the PLA","Xi’an","Shanxi",{"type":69,"coordinates":204},[205,206],113.52486,35.99785,{"lat":206,"lon":205},[209,212],{"name":26,"role":53,"phone":210,"phoneExt":26,"email":211},"029-84717761","tangduec@126.com",{"name":213,"role":50,"phone":26,"phoneExt":26,"email":26},"Liang Wang, Professor",{"facility":215,"status":127,"city":216,"state":217,"zip":26,"country":66,"countryCode":67,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"The Second Affiliated Hospital of Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":69,"coordinates":219},[220,221],120.16142,30.29365,{"lat":221,"lon":220},[224,226],{"name":26,"role":53,"phone":225,"phoneExt":26,"email":26},"021-87315215",{"name":227,"role":50,"phone":26,"phoneExt":26,"email":26},"Chun Wang, Professor",{"type":229,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100600155",false,"NCT07093814","A Study of VRT106 for Injection in Patients With Recurrent\u002FProgressive Glioblastoma","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent\u002FProgressive Glioblastoma","Inclusion Criteria:\n\n* Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.\n* Males and females are aged at 18-70 years (including borderline values) at the time of signing the ICF, male or female.\n* Diagnosed with recurrent\u002Fprogressive glioblastoma.\n* Karnofsky Performance Status (KPS) score ≥60 within 28 days prior to the first administration of the study drug.\n* An expected survival time of≥3 months.\n* Have sufficient organ function.\n* Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first use of the study drug (if a false-positive pregnancy test result is due to non-pregnancy factors such as illness, further testing via ultrasound or other methods is required, and the investigator must confirm the absence of pregnancy before enrollment).\n* Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.\n\nExclusion Criteria:\n\n* Patients with extracranial metastases.\n* Previously received treatment with oncolytic viruses, gene therapy.\n* Subject has received treatment with other unlisted clinical investigational drugs\u002Fdevices within 4 weeks prior to the first dose of VRT106.\n* Subject is known to have an allergic reaction to any of the components of VRT106.\n* Patients who can't have a cranial MRI scan.\n* Women who are breastfeeding.","ALL","18 Years","70 Years",{"count":240,"type":241},42,"ESTIMATED","INTERVENTIONAL",[244,245],"PHASE1","PHASE2","This study is an open-label, single-arm Phase I\u002FII clinical trial with the primary objective of evaluating the safety, tolerability, and efficacy of VRT106 in patients with recurrent\u002Fprogressive glioblastoma.",[248],"Glioblastoma",[248],"2025-12-29",{"date":252,"type":253},"2026-01-02","ACTUAL",{"date":255,"type":253},"2025-09-02",{"date":257,"type":241},"2029-06-30",{"name":5,"class":6},11]