[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563484":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":126,"collaborators":19,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":19,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":19,"enrollmentInfo":137,"targetDuration":19,"studyType":140,"phases":141,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Yuhan Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: YH42946",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","YH42946",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jeesun Lee, MD","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Yuhan Corporation Clinical Operation Team 1","CONTACT","8228280576","clinicaltrials@yuhan.co.kr",[31,45,60,72,87,99,108,117],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":19},"Next Oncology Virginia","TERMINATED","Fairfax","Virginia","22031","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.30637,38.84622,{"lat":43,"lon":42},{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":19,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Seoul National University Bundang Hospital","RECRUITING","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":40,"coordinates":53},[54,55],127.13778,37.43861,{"lat":55,"lon":54},[58],{"name":59,"role":27,"phone":19,"phoneExt":19,"email":19},"Keun-wook Lee",{"facility":61,"status":47,"city":62,"state":49,"zip":63,"country":51,"countryCode":19,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"The Catholic Univ. of Korea St. Vincent's Hospital","Suwon","16247",{"type":40,"coordinates":65},[66,67],127.00889,37.29111,{"lat":67,"lon":66},[70],{"name":71,"role":27,"phone":19,"phoneExt":19,"email":19},"Byoung Yong Shim",{"facility":73,"status":47,"city":74,"state":75,"zip":76,"country":51,"countryCode":19,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Chungbuk National University Hospital","Cheongju-si","North Chungcheong","28644",{"type":40,"coordinates":78},[79,80],127.48972,36.63722,{"lat":80,"lon":79},[83,85],{"name":84,"role":27,"phone":19,"phoneExt":19,"email":19},"Ki-Hyeong Lee",{"name":84,"role":86,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"facility":88,"status":47,"city":89,"state":19,"zip":90,"country":51,"countryCode":19,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Seoul National University Hospital","Seoul","03080",{"type":40,"coordinates":92},[93,94],126.9784,37.566,{"lat":94,"lon":93},[97],{"name":98,"role":27,"phone":19,"phoneExt":19,"email":19},"Do-Youn Oh",{"facility":100,"status":47,"city":89,"state":19,"zip":101,"country":51,"countryCode":19,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Severance Hospital, Yonsei University","03722",{"type":40,"coordinates":103},[93,94],{"lat":94,"lon":93},[106],{"name":107,"role":27,"phone":19,"phoneExt":19,"email":19},"SunMin Lim",{"facility":109,"status":47,"city":89,"state":19,"zip":110,"country":51,"countryCode":19,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Samsung Medical Center","06351",{"type":40,"coordinates":112},[93,94],{"lat":94,"lon":93},[115],{"name":116,"role":27,"phone":19,"phoneExt":19,"email":19},"Sehoon Lee",{"facility":118,"status":47,"city":89,"state":19,"zip":19,"country":51,"countryCode":19,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Asan Medical Center, University of Ulsan",{"type":40,"coordinates":120},[93,94],{"lat":94,"lon":93},[123,125],{"name":124,"role":27,"phone":19,"phoneExt":19,"email":19},"Dae Ho Lee",{"name":124,"role":86,"phone":19,"phoneExt":19,"email":19},{"type":127,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100563484","phase-1-a-phase-12-open-label-multicenter-fih-study-to-evaluate-safety-tolerability-pk-and-anti-tumor-activity-of-yh42946-100563484",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 aberration 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  * Adequate Heart function: QTcF≤ 470 ms, LVEF≥ 50%\n  * Blood Coagulation: INR or Prothrombin time ≤ 1.5 X ULN, aPTT ≤ 1.5 X ULN\n\n\\[Dose Escalation part only\\]\n\n* Histologically or cytologically confirmed diagnosis of advanced, and\u002For metastatic non-hematologic malignancy\n* Documented HER2 aberration or EGFR mutation (HER2 mutation or EGFR exon 20 insertion, HER2 amplification or overexpression)\n\n\\[Dose Expansion part only\\]\n\n* Patients who have at least 1 measurable lesion\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) infection, or active chronic hepatitis B or chronic hepatitis C\n* Major surgery within 4 weeks prior to the first dose of study treatment","ALL","18 Years",{"count":138,"type":139},201,"ESTIMATED","INTERVENTIONAL",[142,143],"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.",[146,147],"NSCLC (Non-small Cell Lung Cancer)","Solid Tumor",[149],"YH42946-101","2026-08-13",{"date":152,"type":153},"2026-08-17","ACTUAL",{"date":155,"type":153},"2024-10-02",{"date":157,"type":139},"2028-07-29",{"name":5,"class":6},8]