[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601156":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":78,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"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,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Chengdu","Sichuan","China","CN",{"type":35,"coordinates":36},"Point",[37,38],104.06667,30.66667,{"lat":38,"lon":37},[41,42,43,45],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":20,"role":24,"phone":20,"phoneExt":20,"email":26},{"name":23,"role":44,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":46,"role":44,"phone":20,"phoneExt":20,"email":20},"Xingchen Peng",{"type":44,"investigatorFullName":46,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Professor",[50],{"name":51,"class":52},"GV20 Therapeutics","INDUSTRY","100601156","phase-1-a-study-of-gv20-0251-in-advanced-or-refractory-solid-tumors-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":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70,71,72,73,74,75,76,77],"HCC - Hepatocellular Carcinoma","Cholangiocarcinoma","Melanoma","NSCLC (Non-small Cell Lung Cancer)","Pancreatic Ductal Adenocarcinoma","HNSCC","Endometrial Cancer","Testicular Cancer",[17],"2025-11-18",{"date":81,"type":82},"2025-11-24","ACTUAL",{"date":84,"type":82},"2025-09-04",{"date":86,"type":64},"2028-06-11",{"name":5,"class":6},1]