[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627618":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":68,"collaborators":24,"id":70,"slug":24,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":24,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":24,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Suzhou Suncadia Biopharmaceuticals Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-A1904 Cohort A Group","EXPERIMENTAL","SHR-A1904 for injection, low dose.",[13],"Drug: SHR-A1904 for Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"SHR-A1904 Cohort B Group","SHR-A1904 for injection, high dose.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","SHR-A1904 for Injection","SHR-A1904 for injection, different doses.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Haoyang Xin","CONTACT","+86-0518-82342973","haoyang.xin.hx5@hengrui.com",[32,52],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":24,"email":49},"Hong Zhao","+86-010-87787100","zhaohong@cicams.ac.cn",{"name":47,"role":51,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":54,"state":55,"zip":56,"country":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Zhongshan Hospital, Fudan University","Shanghai","Shanghai Municipality","200032",{"type":40,"coordinates":58},[59,60],121.45806,31.22222,{"lat":60,"lon":59},[63,67],{"name":64,"role":28,"phone":65,"phoneExt":24,"email":66},"Qiang Gao","+86-021-64041990","gao.qiang@zs-hospital.sh.cn",{"name":64,"role":51,"phone":24,"phoneExt":24,"email":24},{"type":69,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100627618",false,"NCT07450976","A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer","A Phase IIa\u002FIIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n1. Age 18-75 years old (including both ends), male or female;\n2. ECOG-PS score: 0 or 1;\n3. Expected survival ≥ 12 weeks;\n4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;\n5. CLDN18.2 positive expression;\n6. Subjects who failed or intolerance after systemic chemotherapies;\n7. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;\n8. The main organ function is normal, in line with the program requirements;\n9. Consent to contraception.\n\nExclusion Criteria:\n\n1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;\n2. Other active malignancies within 5 years or at the same time;\n3. Subjects with a history or evidence of brain metastasis or meningeal metastasis;\n4. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;\n5. Severe trauma or major surgery was performed within 4 weeks before the first administration;\n6. To study the severe heart disease within 6 months before the first administration;\n7. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;\n8. Severe infection symptoms occurred within 2 weeks before the first administration;\n9. Known hereditary or acquired bleeding and thrombotic tendency;\n10. Congenital or acquired immune defects;\n11. The subjects had severe and uncontrollable concomitant diseases;\n12. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.","ALL","18 Years","75 Years",{"count":80,"type":81},151,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.",[87],"Biliary Tract Cancer","2026-03-30",{"date":90,"type":91},"2026-03-31","ACTUAL",{"date":93,"type":91},"2026-03-25",{"date":95,"type":81},"2030-12",{"name":5,"class":6},2]