[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601156":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":48,"id":52,"slug":20,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":76,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"West China Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GV20-0251 Treatment","EXPERIMENTAL","GV20-0251 safety in Advanced\u002FRefractory Solid Tumors",[13],"Drug: GV20-0251",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","GV20-0251","Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Jin Zhou","CONTACT","+8618980600172","zhoujin096@scu.edu.cn",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":20,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Chengdu","Sichuan","China",{"type":34,"coordinates":35},"Point",[36,37],104.06667,30.66667,{"lat":37,"lon":36},[40,41,42,44],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":20,"role":24,"phone":20,"phoneExt":20,"email":26},{"name":23,"role":43,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":45,"role":43,"phone":20,"phoneExt":20,"email":20},"Xingchen Peng",{"type":43,"investigatorFullName":45,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Professor",[49],{"name":50,"class":51},"GV20 Therapeutics","INDUSTRY","100601156",false,"NCT07106827","A Study of GV20-0251 in Advanced or Refractory Solid Tumors","Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Before conducting any study-specific procedures, voluntarily sign an informed consent form.\n* Be able and willing to participate throughout the entire study period and comply with study procedures.\n* participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)\n* ECOG performance status of 0 or 1 before C1D1\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters\n* Women of childbearing potential (WOCBP) and men must agree to use adequate contraception\n\nExclusion Criteria:\n\n* Participants with acute leukemia or CLL\n* Participant with heart disease, myocardial infarction within the past 6 months, or unstable arrhythmia\n* Fridericia-corrected QT interval (QTcF) \\> 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days of Cycle 1 Day 1 (C1D1)\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.\n* History of major organ transplant and\u002For a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Major surgery within 28 days prior to the first dose of study medication\n* Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.\n* History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.\n* Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.\n* Active substance abuse\n* Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy","ALL","18 Years",{"count":61,"type":62},10,"ESTIMATED","INTERVENTIONAL",[65],"PHASE1","This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg\u002Fkg and 20 mg\u002Fkg dose groups, respectively. The cancer types include solid tumors.",[68,69,70,71,72,73,74,75],"HCC - Hepatocellular Carcinoma","Cholangiocarcinoma","Melanoma","NSCLC (Non-small Cell Lung Cancer)","Pancreatic Ductal Adenocarcinoma","HNSCC","Endometrial Cancer","Testicular Cancer",[17],"2025-11-18",{"date":79,"type":80},"2025-11-24","ACTUAL",{"date":82,"type":80},"2025-09-04",{"date":84,"type":62},"2028-06-11",{"name":5,"class":6},1]