[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508101":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":11,"id":47,"slug":11,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group with SHR-A1811","EXPERIMENTAL",null,[13],"Drug: SHR- A1811",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","SHR- A1811","Subjects with gynaecological malignancies",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Bo Li, Ph.D.","CONTACT","+86 021-61053363","bo.li@hengrui.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Qilu Hospital of Shandong University","RECRUITING","Jinan","Shandong","250012","China",{"type":35,"coordinates":36},"Point",[37,38],116.99722,36.66833,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":11,"email":44},"Beihua Kong, Doctor","+86-18653199168","kongbeihua@sdu.edu.cn",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100508101",false,"NCT05896020","A Study of SHR-A1811 in Subjects With Gynaecologic Oncology","Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies","Inclusion Criteria:\n\n1. The subjects voluntarily joined the study and signed the ICF.\n2. Measurable disease, as defined by RECIST v1.1.\n3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.\n4. Life expectancy ≥ 12 weeks.\n5. Subjects with advanced cervical cancer, recurrent ovarian cancer and endometrial cancer.\n\nExclusion Criteria:\n\n1. Symptomatic, untreated or active central nervous system metastases.\n2. Previously received antibo-conjugated drugs with the following characteristics: topoisomerase I inhibition in the composition Preparations, such as Enhertu (DS-8201a), U3-1402, etc..\n3. Have uncontrolled or severe cardiovascular disease.\n4. With any active autoimmune disease or history of autoimmune disease.\n5. Patients with active hepatitis B or hepatitis C.\n6. Severe infections within 28 days prior to initiation of study treatment.\n7. Active tuberculosis within one year prior to initiation of study treatment.","FEMALE","18 Years","75 Years",{"count":57,"type":58},225,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","This is an open-label, two-part study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with a gynaecological malignancies.",[64],"Gynaecological Malignancies","2023-08-21",{"date":67,"type":68},"2023-08-22","ACTUAL",{"date":70,"type":68},"2023-07-10",{"date":72,"type":58},"2026-06-15",{"name":5,"class":6},1]