[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Virogin Biotech Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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},"100647038","phase-1-a-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-vg2025-intravenous-injection-in-subjects-with-advanced-solid-tumors-100647038",false,"NCT07682870","A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VG2025 Intravenous Injection in Subjects With Advanced Solid Tumors","An Open-label, Multicenter Phase I\u002FIIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of VG2025 Intravenous Treatment in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive); Open to all genders.\n2. Phase I: Participants with advanced solid tumors who have failed standard therapy (due to intolerance or disease progression following treatment) as confirmed by histopathology and\u002For cytology, or for whom no standard therapy is currently approved.\n3. Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).\n4. Within 7 days prior to the first administration of the study drug, female participants of childbearing potential must confirm a negative serum pregnancy test. Participants of childbearing potential and their partners must agree to use effective contraception during the study drug administration period and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Participants experiencing an active herpes simplex virus (HSV) recurrence with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, or genital herpes; or those requiring anti-HSV treatment.\n2. Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.\n3. Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional\u002Fablation therapy within 4 weeks prior to the first dose.\n4. Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.\n5. Any other serious underlying medical conditions, or mental or psychological disorders, hereditary diseases, etc., that, in the investigator's judgment, may interfere with disease staging, treatment, or follow-up; affect the participant's compliance; or place the participant at high risk.\n6. Any other circumstances that, in the investigator's judgment, render the participant unsuitable for participation in the clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","VG2025 is a Recombinant Human IL12\u002F15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.",[28],"Advanced Malignant Solid Tumor","NOT_YET_RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-06","ACTUAL",{"date":35,"type":21},"2026-09-04",{"date":37,"type":21},"2029-09-03",{"name":39,"class":40},"Virogin Biotech Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100633114","phase-2-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-vg2025-in-intrahepatic-cholangiocarcinoma-100633114","NCT07522476","A Clinical Study to Evaluate the Efficacy and Safety of VG2025 in Intrahepatic Cholangiocarcinoma","An Open-label Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of VG2025 in the Treatment of Advanced Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n1. Signed written informed consent form.\n2. Age 18 to 75 years (inclusive), male or female.\n3. Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma.\n4. Eligible participants of childbearing participants(male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.\n\nExclusion Criteria:\n\n1. Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.\n2. Participants who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.\n3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.\n4. Other active uncontrolled infection.\n5. Known alcohol or drug dependence.\n6. Participants with mental disorders or poor compliance.\n7. Women who are pregnant or breastfeeding.\n8. Participants in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.",{"count":50,"type":21},30,[25],"VG2025 is a Recombinant Human IL12\u002F15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.",[54],"Intrahepatic Cholangiocarcinoma","2026-04-07",{"date":57,"type":33},"2026-04-13",{"date":59,"type":21},"2026-07-01",{"date":61,"type":21},"2028-11-13",{"name":39,"class":40},""]