[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598363":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"GV20 Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GV20-0251","EXPERIMENTAL",null,[13],"Drug: GV20-0251",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Part A: Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks Part B: GV20-0251 preliminary RP2D administered by IV infusion once every 3 weeks",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Shanghai Xunbaihui Biotechnology","CONTACT","+8615800557307","clinicaltrials@gv20tx.com",[26,48,53],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41,42,45],{"name":21,"role":22,"phone":11,"phoneExt":11,"email":24},{"name":43,"role":44,"phone":11,"phoneExt":11,"email":11},"Jun Guo, MD","PRINCIPAL_INVESTIGATOR",{"name":46,"role":47,"phone":11,"phoneExt":11,"email":11},"Lu Si, MD","SUB_INVESTIGATOR",{"facility":49,"status":28,"city":29,"state":30,"zip":11,"country":32,"countryCode":33,"cosmosGeoPoint":50,"geoPoint":52,"contacts":11},"Cancer Hospital, Chinese Academy of Medical Sciences",{"type":35,"coordinates":51},[37,38],{"lat":38,"lon":37},{"facility":54,"status":28,"city":55,"state":56,"zip":57,"country":32,"countryCode":33,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Shanghai Pulmonary Hospital","Shanghai","Shanghai Municipality","200437",{"type":35,"coordinates":59},[60,61],121.45806,31.22222,{"lat":61,"lon":60},[64,66],{"name":65,"role":44,"phone":11,"phoneExt":11,"email":11},"Peng Zhang, MD",{"name":67,"role":47,"phone":11,"phoneExt":11,"email":11},"Dongliang Bian, MD",{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100598363","phase-1-study-of-gv20-0251-in-participants-with-solid-tumor-malignancies-100598363",false,"NCT07070518","Study of GV20-0251 in Participants With Solid Tumor Malignancies","An Open-Label Phase 1\u002F2A Study of GV20-0251 in Participants With Advanced and\u002For Refractory Solid Tumor Malignancies","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* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)\n* For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression\n* ECOG performance status of 0 or 1 before C1D1\n* Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible\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 (NYHA ≥ Level II), 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 before 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":80,"type":81},350,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.",[88,89,90,91,92,93,94,95,96],"Solid Tumor Cancer","Adult Refractory Cancer","Endometrial Carcinoma (EC)","Squamous Head and Neck Carcinoma","pMMR\u002FMSS Adenocarcinoma of the Colon or Rectum","Non-Small Cell Lung Cancer","Melanoma","HCC - Hepatocellular Carcinoma","Small Cell Lung Cancer","2025-12-01",{"date":99,"type":100},"2025-12-03","ACTUAL",{"date":102,"type":100},"2025-07-11",{"date":104,"type":81},"2028-09-16",{"name":5,"class":6},3]