[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480185":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":56,"overallOfficials":41,"centralContacts":63,"locations":69,"responsibleParty":131,"collaborators":41,"id":133,"slug":41,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":41,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":41,"enrollmentInfo":141,"targetDuration":41,"studyType":144,"phases":145,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":72,"whyStopped":41,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Anbogen Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1","Determine the maximum tolerated dose (MTD) and RP2D of ABT-101 based on Dose Limiting Toxicities","18 months",{"measure":14,"description":15,"timeFrame":16},"Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation","Patients response according to RECIST 1.1","36 months",[18,22,25,28,31,34,38],{"measure":19,"description":20,"timeFrame":21},"Maximum plasma concentration (Cmax) ABT-101","Plasma concentration of ABT-101","48 months",{"measure":23,"description":24,"timeFrame":21},"Area under the plasma concentration time curve (AUC) of ABT-101","Measure of AUC",{"measure":26,"description":27,"timeFrame":21},"Duration of response (DOR)","DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death",{"measure":29,"description":30,"timeFrame":16},"Progression- free survival (PFS)","Measure of the time from study entry to disease progression or death due to any cause",{"measure":32,"description":33,"timeFrame":16},"Overall survival (OS)","Measure of overall survival",{"measure":35,"description":36,"timeFrame":37},"Objective response rate (ORR) in Part 1","Objective response rate as determined by RECIST 1.1","12 months",{"measure":39,"description":40,"timeFrame":16},"Disease control rate (DCR)","DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"NA","SINGLE_GROUP","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","This study will be conducted in two parts:\n\nPart 1: Dose- Escalation, Phase 1b, is designed to determine the RP2D. Patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (DLTs). DLT assessment will be conducted during treatment cycle 1\n\nPart 2: Dose- Expansion, Phase 2, will evaluate the safety and efficacy of ABT-101 at the dosage and dosing regime determined in Phase 1b. Phase 2 will enroll NSCLC patients with HER2 mutations\n\nStudy participation for all patients includes screening period, treatment period and safety\u002F follow-up period. Patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met",[50],{"label":51,"type":52,"description":53,"interventionNames":54},"ABT-101","EXPERIMENTAL","Part 1- dose-escalation: ABT-101 in patients with advanced cancer disease\n\nPart 2- dose expansion: ABT-101 in patients with NSCLC with confirmed HER2 mutations",[55],"Drug: ABT-101",[57],{"type":58,"name":51,"description":59,"armGroupLabels":60,"otherNames":61},"DRUG","Patients will receive ABT-101 by oral administration on a 28-day cycle",[51],[62],"DBPR112",[64],{"name":65,"role":66,"phone":67,"phoneExt":41,"email":68},"Anbogen","CONTACT","+886-2-2742-1839","clinicaltrial@anbogen.com",[70,86,98,110,119],{"facility":71,"status":72,"city":73,"state":41,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Taichung Veterans General Hospital","RECRUITING","Taichung","40705","Taiwan","TW",{"type":78,"coordinates":79},"Point",[80,81],120.6839,24.1469,{"lat":81,"lon":80},[84],{"name":85,"role":66,"phone":41,"phoneExt":41,"email":41},"Tsung-Ying Yang, M.D",{"facility":87,"status":72,"city":88,"state":41,"zip":89,"country":75,"countryCode":76,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"National Cheng Kung University Hospital","Tainan","70403",{"type":78,"coordinates":91},[92,93],120.21333,22.99083,{"lat":93,"lon":92},[96],{"name":97,"role":66,"phone":41,"phoneExt":41,"email":41},"Wu-Chou Su, M.D",{"facility":99,"status":72,"city":100,"state":41,"zip":101,"country":75,"countryCode":76,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"National Taiwan University Hospital","Taipei","10002",{"type":78,"coordinates":103},[104,105],121.52639,25.05306,{"lat":105,"lon":104},[108],{"name":109,"role":66,"phone":41,"phoneExt":41,"email":41},"Chia-Chi Lin, M.D",{"facility":111,"status":72,"city":100,"state":41,"zip":112,"country":75,"countryCode":76,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Taipei Medical Univresity Hospital","11031",{"type":78,"coordinates":114},[104,105],{"lat":105,"lon":104},[117],{"name":118,"role":66,"phone":41,"phoneExt":41,"email":41},"Chao-Hua Chiu, M.D",{"facility":120,"status":72,"city":121,"state":41,"zip":122,"country":75,"countryCode":76,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Chang Gung Memorial Hospital, Linkou","Taoyuan","33305",{"type":78,"coordinates":124},[125,126],121.29696,24.99368,{"lat":126,"lon":125},[129],{"name":130,"role":66,"phone":41,"phoneExt":41,"email":41},"Wen-Cheng Chang, M.D",{"type":132,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100480185",false,"NCT05532696","Phase 1b\u002F2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ABT-101 in Patients With Advanced Solid Tumors and HER2 Exon 20 Insertions Mutated Non- Small Cell Lung Cancer","Inclusion Criteria:\n\n* Male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent\n* Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2)\n* For patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2)\n* Appropriate candidate for experimental therapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known active or untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.\n* Serious acute or chronic infections\n* Received a live-virus vaccination\n* Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.\n* Not recovered from prior- treatment toxicities to Grade ≤1\n* Major surgery within 28 days prior to the study treatment\n* Concurrent malignancy within 2 years prior to first dose\n* History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms\n* Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101\n* Known to have a history of alcoholism or drug abuse","ALL","18 Years",{"count":142,"type":143},61,"ESTIMATED","INTERVENTIONAL",[146,147],"PHASE1","PHASE2","A Phase 1b\u002F2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)",[150,151,152],"Advanced Solid Tumor","Non Small Cell Lung Cancer","HER2 Mutations",[51,154,152],"NSCLC","2024-06-21",{"date":157,"type":158},"2024-06-24","ACTUAL",{"date":160,"type":158},"2022-09-27",{"date":162,"type":143},"2027-05",{"name":5,"class":6},5]