[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563484":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":128,"collaborators":19,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":19,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":19,"enrollmentInfo":139,"targetDuration":19,"studyType":142,"phases":143,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"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},"Judith Ertle, 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",[31,48,62,74,89,101,110,119],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Next Oncology Virginia","RECRUITING","Fairfax","Virginia","22031","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.30637,38.84622,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":19,"phoneExt":19,"email":19},"Alexander I. 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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":140,"type":141},161,"ESTIMATED","INTERVENTIONAL",[144,145],"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.",[148,149],"NSCLC (Non-small Cell Lung Cancer)","Solid Tumor",[151],"YH42946-101","2025-11-02",{"date":154,"type":155},"2025-11-04","ACTUAL",{"date":157,"type":155},"2024-10-02",{"date":159,"type":141},"2028-07-29",{"name":5,"class":6},8]