[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612977":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"The First Affiliated Hospital of Xinxiang Medical College","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VSV-02 Dose Escalation Group","EXPERIMENTAL","Participants will receive VSV-02 via intravenous (IV) and intratumoral (IT) injection in a dose-escalation manner. The starting dose is 6×10\\^10 PFU (IT) + 6×10\\^11 PFU (IV). Dosing occurs on Day 1 of each 21-day cycle for up to 6 cycles.",[13],"Biological: VSV-02 Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","VSV-02 Injection","VSV-02 Injection is an oncolytic virus vaccine based on an attenuated Vesicular Stomatitis Virus (VSV) that is engineered to encode a CD3\u002FPD-L1 bispecific antibody. It is supplied as a sterile solution by Shanghai Rongrui Pharmaceutical Technology Co., Ltd., with a specification of 1 mL per vial and a viral titer of 3.0×10\\^10 PFU\u002FmL.\n\nThe investigational product is administered via two routes: intratumoral (IT) injection followed by intravenous (IV) infusion on Day 1 (D1) of each 21-day treatment cycle. Patients may receive up to 6 cycles of treatment.\n\nIn this dose-escalation study, participants are enrolled into predefined dose cohorts. The starting dose for the first cohort is 6×10\\^10 PFU via intratumoral injection and 6×10\\^11 PFU via intravenous infusion.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"LiuZhong Yang, master","First Affiliated Hospital of Xinjiang Medical University","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","8613639638824","56236053@qq.com",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The First Affiliated Hospital of Xinxiang Medical University","RECRUITING","Xinxiang","Henan","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.80151,35.19033,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":20,"email":49},"Ping Lu, Ph.D.","13598722864","lupingdoctor@126.com",{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100612977","phase-1-vsv-02-compassionate-use-in-advanced-solid-tumors-100612977",false,"NCT07260591","VSV-02 Compassionate Use in Advanced Solid Tumors","A Single-Arm, Open-Label, Compassionate Use Study of VSV-02 Administered Intravenously and Intratumorally in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nVoluntary signed informed consent.\n\nAge ≥ 18 years.\n\nHistologically or cytologically confirmed advanced solid tumor (e.g., melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer).\n\nDisease progression after at least two prior lines of standard therapy (including targeted therapy), or for whom no standard therapy exists or is medically unsuitable.\n\nAt least one measurable lesion per RECIST 1.1 criteria.\n\nAt least one lesion accessible for intratumoral injection.\n\nECOG performance status of 0-2.\n\nLife expectancy ≥ 12 weeks.\n\nAdequate organ and bone marrow function.\n\nNegative pregnancy test for women of childbearing potential.\n\nAgreement to use effective contraception during the study and for at least 6 months after the last dose.\n\nExclusion Criteria:\n\nSymptomatic or untreated brain metastases (asymptomatic or stable for ≥3 months after local therapy allowed).\n\nRadiotherapy to the target lesion within 2 months.\n\nHistory of other active malignancy within 5 years (with specific exceptions).\n\nLesion intended for injection with a longest diameter \\> 100 mm.\n\nParticipation in another interventional clinical trial within 4 weeks.\n\nPrior or planned organ\u002Ftissue transplantation.\n\nActive HIV, Hepatitis B, Hepatitis C, or Syphilis infection meeting specific criteria.\n\nRequirement for concomitant antiviral or therapeutic anticoagulation.\n\nUncontrolled ≥ Grade 3 active infection.\n\nSpecific washout periods for prior anti-cancer therapies not met.\n\nUncontrolled cardiovascular disease.\n\nActive or history of autoimmune disease (with specific exceptions).\n\nRequirement for systemic corticosteroids (\\>10 mg prednisone equivalent) within 14 days or during the study.\n\nTumors located in high-risk anatomical sites.\n\nAdministration of live vaccines during the study period.\n\nKnown hypersensitivity to any component of the study drug or related immunotherapies.\n\nHistory of severe mental illness, substance abuse, or other conditions that may interfere with study compliance.\n\nPregnancy or lactation.\n\nToxicities from previous anti-cancer therapy not recovered to ≤ Grade 1 (except alopecia).\n\nAny other condition deemed inappropriate for participation by the investigator.","ALL","18 Years",{"count":62,"type":63},6,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","This is a clinical study for patients with advanced solid tumors who have limited or no effective treatment options available. The study aims to evaluate a new investigational drug called VSV-02 Injection, which is developed by Shanghai Rongrui Pharmaceutical Technology Co., Ltd.\n\nThe main purpose of this open-label, single-arm study is to assess the preliminary effectiveness and safety of VSV-02 when it is given through two routes: directly into a vein (intravenously) and by injection directly into the tumor (intratumorally). Patients will receive the treatment on the first day of each 3-week cycle, for up to 6 cycles.\n\nThe study will follow a dose-escalation design to find a suitable dose. Treatment may be stopped if the disease progresses, if side effects become intolerable, or if the patient chooses to withdraw, among other reasons. Researchers will closely monitor patients to see if VSV-02 can help control the cancer and to record any side effects that may occur.",[69,70,71,72,73,74],"Advanced Solid Tumor","Melanoma","Breast Cancer","Lung Cancer","Cancer Treatment","Immunotherapy","2025-11-28",{"date":77,"type":78},"2025-12-03","ACTUAL",{"date":80,"type":78},"2025-09-22",{"date":82,"type":63},"2027-09-30",{"name":5,"class":6},1]