[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629952":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":16,"centralContacts":51,"locations":57,"responsibleParty":86,"collaborators":16,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":16,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":16,"enrollmentInfo":97,"targetDuration":16,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":16,"overallStatus":60,"whyStopped":16,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Dong-A ST Co., Ltd.","INDUSTRY",[8,14,18,21,24,27,30,33,36,39,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1","EXPERIMENTAL","Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.",[13],"Drug: DA-3501",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Level 2",null,[13],{"label":19,"type":10,"description":16,"interventionNames":20},"Dose Level 3",[13],{"label":22,"type":10,"description":16,"interventionNames":23},"Dose Level 4",[13],{"label":25,"type":10,"description":16,"interventionNames":26},"Dose Level 5",[13],{"label":28,"type":10,"description":16,"interventionNames":29},"Dose Level 6",[13],{"label":31,"type":10,"description":16,"interventionNames":32},"Dose Level 7",[13],{"label":34,"type":10,"description":16,"interventionNames":35},"Dose Level 8",[13],{"label":37,"type":10,"description":16,"interventionNames":38},"Dose Level 9",[13],{"label":40,"type":10,"description":16,"interventionNames":41},"Dose Level 10",[13],{"label":43,"type":10,"description":16,"interventionNames":44},"Dose Level 11",[13],[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":16},"DRUG","DA-3501","Participant will receive DA-3501 at the assigned dose level administered intravenously once every three weeks.",[9,40,43,15,19,22,25,28,31,34,37],[52],{"name":53,"role":54,"phone":55,"phoneExt":16,"email":56},"Jiwon Shin","CONTACT","82-2-920-8768","jiwon_shin@donga.co.kr",[58,71,77],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":16,"cosmosGeoPoint":65,"geoPoint":70,"contacts":16},"CHA University Bundang Medical Center","RECRUITING","Seongnam","Bundang","13496","South Korea",{"type":66,"coordinates":67},"Point",[68,69],127.7548,36.4052,{"lat":69,"lon":68},{"facility":72,"status":60,"city":61,"state":62,"zip":73,"country":64,"countryCode":16,"cosmosGeoPoint":74,"geoPoint":76,"contacts":16},"Seoul National University Bundang Hospital","13620",{"type":66,"coordinates":75},[68,69],{"lat":69,"lon":68},{"facility":78,"status":60,"city":79,"state":79,"zip":80,"country":64,"countryCode":16,"cosmosGeoPoint":81,"geoPoint":85,"contacts":16},"Severance Hospital","Seoul","03722",{"type":66,"coordinates":82},[83,84],126.9784,37.566,{"lat":84,"lon":83},{"type":87,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100629952","phase-1-a-first-in-human-phase-iiia-study-to-evaluate-da-3501-in-patients-with-advanced-gastric-or-gastro-esophageal-junction-adenocarcinoma-and-pancreatic-ductal-adenocarcinoma-100629952",false,"NCT07481357","A First-In-Human Phase I\u002FIIa Study to Evaluate DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma","A First-In-Human Phase I\u002FIIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. Patients aged ≥ 19 years\n2. Histologically or cytologically documented advanced CLDN18.2+ GC\u002FGEJ adenocarcinoma or advanced CLDN18.2+ PDAC\n3. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n4. Life expectancy ≥12 weeks as judged by the Investigator\n\nExclusion Criteria:\n\n1. Cardiac abnormalities\n2. Gastrointestinal abnormalities\n3. Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV).\n4. Active systemic infection requiring IV antibiotics therapy.","ALL","19 Years",{"count":98,"type":99},51,"ESTIMATED","INTERVENTIONAL",[102],"PHASE1","The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC\u002FGEJ and advanced CLDN18.2+ PDAC.\n\nParticipants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.",[105,106,107],"Gastric (Stomach) Cancer","GastroEsophageal Cancer","Pancreatic Ductal Adenocarcinoma (mPDAC)","2026-05-18",{"date":110,"type":111},"2026-05-20","ACTUAL",{"date":108,"type":111},{"date":114,"type":99},"2029-02",{"name":5,"class":6},3]