[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627618":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":69,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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",[32,53],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Hong Zhao","+86-010-87787100","zhaohong@cicams.ac.cn",{"name":48,"role":52,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":34,"city":55,"state":56,"zip":57,"country":38,"countryCode":39,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Zhongshan Hospital, Fudan University","Shanghai","Shanghai Municipality","200032",{"type":41,"coordinates":59},[60,61],121.45806,31.22222,{"lat":61,"lon":60},[64,68],{"name":65,"role":28,"phone":66,"phoneExt":24,"email":67},"Qiang Gao","+86-021-64041990","gao.qiang@zs-hospital.sh.cn",{"name":65,"role":52,"phone":24,"phoneExt":24,"email":24},{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100627618","phase-2-a-study-of-shr-a1904-in-previous-systemic-treatment-failed-biliary-tract-cancer-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":82,"type":83},151,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89],"Biliary Tract Cancer","2026-03-30",{"date":92,"type":93},"2026-03-31","ACTUAL",{"date":95,"type":93},"2026-03-25",{"date":97,"type":83},"2030-12",{"name":5,"class":6},2]