[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biliary-tract-or-colorectal-cancer-with-her2-positivemutated\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biliary-tract-or-colorectal-cancer-with-her2-positivemutated":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100549482","phase-2-a-clinical-study-of-sph5030-tablets-in-the-treatment-of-her2-positivemutated-biliary-tract-or-colorectal-cancer-patients-100549482",false,"NCT06434597","A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive\u002FMutated Biliary Tract OR Colorectal Cancer Patients.","A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive\u002FMutated Biliary Tract OR Colorectal Cancer.","Inclusion Criteria:\n\n1. Metastatic and\u002For unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and\u002For unresectable advanced biliary tract carcinoma\n2. HER2 positive or HER2 gene mutation;\n3. Meet the requirements of previous treatment;\n4. ECOG performance status of 0 or 1；\n5. Expected survival ≥ 3 months;\n6. No serious abnormalities in hematopoietic function, liver or kidney function;\n7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;\n8. Fully informed subjects who voluntarily sign the ICF.\n\nExclusion Criteria:\n\n1. Subjects who have previously received anti-HER2 molecular targeted therapy;\n2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;\n3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;\n\n5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive\u002Fmutated biliary tract OR colorectal cancer.",[26],"Biliary Tract or Colorectal Cancer With Her2-positive\u002FMutated","RECRUITING","2025-08-15",{"date":30,"type":31},"2025-08-17","ACTUAL",{"date":33,"type":31},"2024-07-17",{"date":35,"type":20},"2026-12-31",{"name":37,"class":38},"Shanghai Pharmaceuticals Holding Co., Ltd","INDUSTRY",30]