[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563484":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":38,"armGroups":43,"interventions":50,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":163,"collaborators":38,"id":165,"slug":38,"hasResults":166,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":38,"eligibilityCriteria":170,"healthyVolunteers":166,"sex":171,"minAge":172,"maxAge":38,"enrollmentInfo":173,"targetDuration":38,"studyType":176,"phases":177,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":68,"whyStopped":38,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Yuhan Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Treatment Emergent Adverse Events(TEAE)s","To assess the safety and tolerability of YH42946","Through study completion, during the first 21 days of DLT evaluation period.",{"measure":14,"description":15,"timeFrame":16},"Objective Response Rate (ORR)","Anti-tumor activity according to RECIST v1.1","Through dose expansion part completion, approximately 12 months",[18,22,24,26,28],{"measure":19,"description":20,"timeFrame":21},"AUClast","To characterize the pharmacokinetics (PK) of YH42946","Through study completion, approximately 12 months",{"measure":23,"description":20,"timeFrame":21},"AUCinf",{"measure":25,"description":20,"timeFrame":21},"Cmax",{"measure":27,"description":20,"timeFrame":21},"Tmax",{"measure":14,"description":29,"timeFrame":21},"To assess the anti-tumor activity according to RECIST v1.1",[31],{"measure":32,"description":33,"timeFrame":34},"Overall survival(OS)","To assess the overall survival of YH42946","Through study completion, approximately 3.5 year",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":38,"timePerspective":38,"maskingInfo":40},"NA","SEQUENTIAL",null,"TREATMENT",{"masking":41,"maskingDescription":38,"whoMasked":38},"NONE","YH42946 is a novel, orally available tyrosine kinase inhibitor targeting HER2. YH42946 showed potency for diverse HER2 aberrations including HER2 overexpression, amplification, or mutation, as well as EGFR Ex20ins.\n\nThis is a Phase 1\u002F2, open-label, multicenter, first-in-human study of YH42946. The study has 2 parts. The first part is dose escalation part to identify the maximum tolerated dose. The second part is dose expansion part to select 2 doses for RD selection at the first cohort, after then RD will be determined to ensure its efficacy. Several independent cohorts are planned.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"Part 1 and Part 2","EXPERIMENTAL","Part 1: Dose escalation arm to determine the MTD Part 2: Dose expansion part to select RD. Several independent cohorts are planned.",[49],"Drug: YH42946",[51],{"type":52,"name":53,"description":53,"armGroupLabels":54,"otherNames":38},"DRUG","YH42946",[45],[56],{"name":57,"affiliation":5,"role":58},"Judith Ertle, MD","STUDY_DIRECTOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":38,"email":64},"Yuhan Corporation Clinical Operation Team 1","CONTACT","8228280576","clinicaltrials@yuhan.co.kr",[66,83,97,109,124,136,145,154],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Next Oncology Virginia","RECRUITING","Fairfax","Virginia","22031","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-77.30637,38.84622,{"lat":78,"lon":77},[81],{"name":82,"role":62,"phone":38,"phoneExt":38,"email":38},"Alexander I. Spira",{"facility":84,"status":68,"city":85,"state":86,"zip":87,"country":88,"countryCode":38,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Seoul National University Bundang Hospital","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":75,"coordinates":90},[91,92],127.13778,37.43861,{"lat":92,"lon":91},[95],{"name":96,"role":62,"phone":38,"phoneExt":38,"email":38},"Keun-wook Lee",{"facility":98,"status":68,"city":99,"state":86,"zip":100,"country":88,"countryCode":38,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"The Catholic Univ. of Korea St. Vincent's Hospital","Suwon","16247",{"type":75,"coordinates":102},[103,104],127.00889,37.29111,{"lat":104,"lon":103},[107],{"name":108,"role":62,"phone":38,"phoneExt":38,"email":38},"Byoung Yong Shim",{"facility":110,"status":68,"city":111,"state":112,"zip":113,"country":88,"countryCode":38,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Chungbuk National University Hospital","Cheongju-si","North Chungcheong","28644",{"type":75,"coordinates":115},[116,117],127.48972,36.63722,{"lat":117,"lon":116},[120,122],{"name":121,"role":62,"phone":38,"phoneExt":38,"email":38},"Ki-Hyeong Lee",{"name":121,"role":123,"phone":38,"phoneExt":38,"email":38},"PRINCIPAL_INVESTIGATOR",{"facility":125,"status":68,"city":126,"state":38,"zip":127,"country":88,"countryCode":38,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Seoul National University Hospital","Seoul","03080",{"type":75,"coordinates":129},[130,131],126.9784,37.566,{"lat":131,"lon":130},[134],{"name":135,"role":62,"phone":38,"phoneExt":38,"email":38},"Do-Youn Oh",{"facility":137,"status":68,"city":126,"state":38,"zip":138,"country":88,"countryCode":38,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"Severance Hospital, Yonsei University","03722",{"type":75,"coordinates":140},[130,131],{"lat":131,"lon":130},[143],{"name":144,"role":62,"phone":38,"phoneExt":38,"email":38},"Byoung Chul Cho",{"facility":146,"status":68,"city":126,"state":38,"zip":147,"country":88,"countryCode":38,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Samsung Medical Center","06351",{"type":75,"coordinates":149},[130,131],{"lat":131,"lon":130},[152],{"name":153,"role":62,"phone":38,"phoneExt":38,"email":38},"Sehoon Lee",{"facility":155,"status":68,"city":126,"state":38,"zip":38,"country":88,"countryCode":38,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Asan Medical Center, University of Ulsan",{"type":75,"coordinates":157},[130,131],{"lat":131,"lon":130},[160,162],{"name":161,"role":62,"phone":38,"phoneExt":38,"email":38},"Sang-We Kim",{"name":161,"role":123,"phone":38,"phoneExt":38,"email":38},{"type":164,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100563484",false,"NCT06616766","A Phase 1\u002F2, Open-label, Multicenter, FIH Study to Evaluate Safety, Tolerability, PK and Anti-tumor Activity of YH42946","A Phase 1\u002F2, Open-label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, PK and Anti-tumor Activity of YH42946 in Patients With Locally Advanced or Metastatic Solid Tumors With HER2 Aberration and EGFR Exon 20 Insertion","Inclusion Criteria:\n\n* ECOG performance status 0 or 1\n* Estimated life expectancy of at least 3 months\n* Patients who have progressed on or after all available standard therapies or for whom standard treatment is inappropriate\n* Mandatory provision of archived or fresh tumor tissue in quantity sufficient to allow for retrospective confirmation of HER2 or EGFR mutation\n* A patient with a history of brain metastases must have had all lesions treated\n* Adequate organ function defined as all of the following:\n\n  * Adequate bone marrow function (within 1 week prior to first administration): Neutrophils≥1.5 x10\\*9 cells\u002FL (Criteria must be met without the use of Granulocyte-Colony Stimulating Factor (G-CSF) within last week prior to testing.); platelet count≥75 x10\\*9 cells\u002FL; Hb ≥9g\u002FdL (Criteria must be met without packed red blood cell (pRBC) transfusion within last week prior to testing.)\n  * Adequate hepatic function: Serum bilirubin≤1.5 x upper limit of normal (ULN), and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases (within 1 week prior to first administration)\n  * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin per 1.73 m\\*2 according to the site's calculation method.\n\n\\[Dose Escalation part only\\]\n\n* Histologically or cytologically confirmed diagnosis of advanced, and\u002For metastatic non-hematologic malignancy\n* Documented HER2 or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)\n\n\\[Dose Expansion part only\\]\n\n* Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC HER2 exon 20 insertion (Cohort 1)\n\nExclusion Criteria:\n\n* Patient with symptomatic or progressive brain metastases\n* Known or suspected leptomeningeal disease (LMD)\n* Uncontrolled spinal cord compression\n* History of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks\n* History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n* Medical, psychiatric, cognitive or other conditions that compromise the patients ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study\n* Any severe concurrent disease or condition (includes active infections, cardiac arrhythmia) that in the judgment of the Investigator would make study participation inappropriate for the patient\n* History of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis\n* History of a second primary cancer with the exception of\n\n  1. curatively treated non-melanomatous skin cancer,\n  2. curatively treated cervical or breast carcinoma in situ, or\n  3. other malignancy with no known active disease present and no treatment administered during the last 2 years\n* Infection with human immunodeficiency virus (HIV) or prior hepatitis B or active chronic hepatitis B or active hepatitis C\n* Major surgery within 4 weeks prior to the first dose of study treatment","ALL","18 Years",{"count":174,"type":175},161,"ESTIMATED","INTERVENTIONAL",[178,179],"PHASE1","PHASE2","The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.",[182,183],"NSCLC (Non-small Cell Lung Cancer)","Solid Tumor",[185],"YH42946-101","2025-11-02",{"date":188,"type":189},"2025-11-04","ACTUAL",{"date":191,"type":189},"2024-10-02",{"date":193,"type":175},"2028-07-29",{"name":5,"class":6},8]