[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579593":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":13,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":62,"id":66,"slug":13,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":13,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":13,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":43,"whyStopped":13,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Guangzhou Virotech Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors","To evaluate the safety and tolerability of VRT106 in patients with locally advanced\u002Fmetastatic solid tumours 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.","About 2 years",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","To evaluate VRT106 for injection in patients with locally advanced\u002Fmetastatic solid tumours for safety and tolerability, exploring the maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD)\u002Foptimal bioavailable dose (OBD) and\u002For the recommended phase II clinical dose (RP2D) to provide a recommended dose for subsequent clinical trials.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"VRT106 for injection","EXPERIMENTAL","VRT106 will be administered through IV drip",[27],"Biological: VRT106",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"BIOLOGICAL","VRT106","Intravenous drip administration",[23],[35],{"name":36,"role":37,"phone":38,"phoneExt":13,"email":39},"Third Affiliated Hospital, Sun Yat-sen University","CONTACT","+86-020-32030745","clinicaltrialinfo@virot.cn",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Third Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.25,23.11667,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":13,"email":59},"Liang Peng Principal Investigator, Ph.D; Professor","+86-13556065609","pliang@mail.sysu.edu.cn",{"type":61,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR",[63],{"name":64,"class":65},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER","100579593",false,"NCT06826313","A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors","An Open-labeled Phase I Clinical Trial Evaluating the Safety, Tolerability, Biodistribution Characteristics, Biological EEffects, and Initial Efficacy of VRT106 for Injection in the Treatment of Locally Advanced\u002FMetastatic Solid Tumors by Intravenous Administration","Inclusion Criteria:\n\n1. 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.\n2. Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.\n3. Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.\n4. Subjects have at least one measurable lesion.\n5. ECOG score of 0 to 28 days prior to first dose of IMP.\n6. An expected survival time of ≥ 12 weeks.\n7. Have sufficient organ function.\n8. Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug.\n9. 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\n1. Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP.\n2. Subject has previously received oncolytic virus or other gene drug therapy.\n3. Subject has received treatment with other unlisted clinical investigational drugs\u002Fdevices within 4 weeks prior to the first dose of IMP.\n4. Subject is known to have an allergic reaction to any of the components of IMP.\n5. Women who are breastfeeding.","ALL","18 Years","75 Years",{"count":76,"type":77},12,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors",[83],"Solid Tumors",[85,86,31],"Solid Tumor","Oncolytic Virus","2025-07-15",{"date":89,"type":90},"2025-07-18","ACTUAL",{"date":92,"type":90},"2025-03-19",{"date":94,"type":77},"2027-03-01",{"name":5,"class":6},1]