[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568953":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":84,"collaborators":86,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":19,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":19,"enrollmentInfo":103,"targetDuration":19,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":115,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Aptamer Sciences, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"AST-201","EXPERIMENTAL","Participants receive AST-201 administered intravenously according to the study dosing schedule.",[13],"Drug: AST-201",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","AST-201 is administered intravenously on Days 1, 8, and 15 of each 28-day cycle, followed by a one-week rest period. Dosing is repeated until DLT or disease progression is occurred.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"David Lee","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Aptamer Sciences Inc.","CONTACT","+82-70-5067-4275","kjkim@aptsci.com",[31,51,63,75],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":19,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"National Cancer Center, Korea","RECRUITING","Goyang-si","Gyeonggi-do","10408","South Korea",{"type":39,"coordinates":40},"Point",[41,42],126.835,37.65639,{"lat":42,"lon":41},[45,48],{"name":46,"role":47,"phone":19,"phoneExt":19,"email":19},"Sang Myung Woo, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":49,"role":50,"phone":19,"phoneExt":19,"email":19},"Bo Hyun Kim, MD, PhD","SUB_INVESTIGATOR",{"facility":52,"status":33,"city":53,"state":19,"zip":54,"country":37,"countryCode":19,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"CHA Bundang Medical Center","Seongnam","13609",{"type":39,"coordinates":56},[57,58],127.7548,36.4052,{"lat":58,"lon":57},[61],{"name":62,"role":47,"phone":19,"phoneExt":19,"email":19},"Hong Jae Chon, MD, PhD",{"facility":64,"status":33,"city":65,"state":19,"zip":66,"country":37,"countryCode":19,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Severance Hospital","Seoul","03722",{"type":39,"coordinates":68},[69,70],126.9784,37.566,{"lat":70,"lon":69},[73],{"name":74,"role":47,"phone":19,"phoneExt":19,"email":19},"Hye Ryun Kim, MD, PhD.",{"facility":76,"status":33,"city":65,"state":19,"zip":77,"country":37,"countryCode":19,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Samsung Medical Center","06351",{"type":39,"coordinates":79},[69,70],{"lat":70,"lon":69},[82],{"name":83,"role":47,"phone":19,"phoneExt":19,"email":19},"Jung Yong Hong, MD, PhD",{"type":85,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[87,90,92,93],{"name":88,"class":89},"CHA University","OTHER",{"name":32,"class":91},"OTHER_GOV",{"name":76,"class":89},{"name":64,"class":89},"100568953","phase-1-a-study-to-evaluate-the-tolerability-safety-and-pk-of-ast-201-in-patients-with-gpc3-positive-advanced-solid-tumors-100568953",false,"NCT06687941","A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors","A Multi-center, Open-label, Dose Escalation and Expansion, Phase 1 Study to Evaluate the Tolerability, Safety and Pharmacokinetics of AST-201 in Patients With GPC3-positive Advanced Solid Tumors","Inclusion Criteria\n\n* Male and female aged ≥19 years\n* Histologically and\u002For cytologically diagnosed as the advanced recurrent solid tumor\n* GPC3-positive confirmed by IHC test\n* At least 1 measurable or non-measurable but evaluable lesion as defined per RECIST v1.1 (modified RECIST for hepatocellular carcinoma)\n* ECOG performance status of 0 or 1\n* Life expectancy at least 12 weeks\n* Adequate hematologic, hepatic, renal, and heart\u002Fcoagulation function\n* Child-Pugh Class of A for HCC\n\nExclusion Criteria\n\n* Subjects with ischemic heart disease\n* Subjects with anti-tumor treatment within 4 weeks\n* Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc.\n* Pregnant or potentially pregnant and lactating woman","ALL","19 Years",{"count":104,"type":105},70,"ESTIMATED","INTERVENTIONAL",[108],"PHASE1","This is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.",[111,112,113,114],"Neoplasms","Carcinoma, Hepatocellular","Carcinoma, Non-Small-Cell Lung","Liver Neoplasms",[116,117,9,118,119,120,121,122],"Glypican-3 (GPC3)","GPC3-positive advanced solid tumors","Aptamer-drug conjugate","Hepatocellular carcinoma (HCC)","Advanced solid tumors","Metastatic","Dose Escalation and Expansion","2026-03-23",{"date":125,"type":126},"2026-03-27","ACTUAL",{"date":128,"type":126},"2025-03-11",{"date":130,"type":105},"2028-05",{"name":5,"class":6},4]