[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508101":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"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,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Qilu Hospital of Shandong University","RECRUITING","Jinan","Shandong","250012","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.99722,36.66833,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":11,"email":45},"Beihua Kong, Doctor","+86-18653199168","kongbeihua@sdu.edu.cn",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100508101","phase-2-a-study-of-shr-a1811-in-subjects-with-gynaecologic-oncology-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":59,"type":60},225,"ESTIMATED","INTERVENTIONAL",[63],"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.",[66],"Gynaecological Malignancies","2023-08-21",{"date":69,"type":70},"2023-08-22","ACTUAL",{"date":72,"type":70},"2023-07-10",{"date":74,"type":60},"2026-06-15",{"name":5,"class":6},1]