[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566381":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":36,"studyPopulation":36,"armGroups":49,"interventions":55,"overallOfficials":36,"centralContacts":60,"locations":66,"responsibleParty":86,"collaborators":36,"id":88,"slug":36,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":36,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":36,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":36,"overallStatus":69,"whyStopped":36,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR)","Assessed by Investigator according to RECIST 1.1 criteria.","Radiological scans performed at baseline then every 6 weeks up to 36 weeks, then every 9 weeks thereafter,up to approximately 24 months.",[14,16,18,20,22,26,30,34,37,39,41],{"measure":15,"description":11,"timeFrame":12},"Duration of response (DoR)",{"measure":17,"description":11,"timeFrame":12},"Disease control rate (DCR)",{"measure":19,"description":11,"timeFrame":12},"Time to response (TTR)",{"measure":21,"description":11,"timeFrame":12},"Progression free survival (PFS)",{"measure":23,"description":24,"timeFrame":25},"Overall survival (OS)","OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.","follow up once every 60 days. Up to approximately 36 months.",{"measure":27,"description":28,"timeFrame":29},"12 month survival rate","Survival rate within one year.","follow up once every 60 days. Up to approximately 24 months.",{"measure":31,"description":32,"timeFrame":33},"Adverse Events (AEs)","Include incidence,grade(judged according to NCI-CTCAE V5.0 standards).","Up to approximately 24 months.",{"measure":35,"description":36,"timeFrame":33},"PK traits of SHR-A2102: Plasma concentrations of SHR-A2102.",null,{"measure":38,"description":36,"timeFrame":33},"PK traits of SHR-A2102: Plasma concentrations of SHR-A2102 metabolites.",{"measure":40,"description":36,"timeFrame":33},"ADA traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.",{"measure":42,"description":36,"timeFrame":33},"Nab traits of SHR-A2102: Serum concentrations of SHR-A2102 at each planned blood collection time point.",{"allocation":44,"interventionModel":45,"interventionModelDescription":36,"primaryPurpose":46,"observationalModel":36,"timePerspective":36,"maskingInfo":47},"NA","SINGLE_GROUP","TREATMENT",{"masking":48,"maskingDescription":36,"whoMasked":36},"NONE",[50],{"label":51,"type":52,"description":36,"interventionNames":53},"Single Group","EXPERIMENTAL",[54],"Drug: SHR-A2102 for injection",[56],{"type":57,"name":58,"description":58,"armGroupLabels":59,"otherNames":36},"DRUG","SHR-A2102 for injection",[51],[61],{"name":62,"role":63,"phone":64,"phoneExt":36,"email":65},"ZhiFei Lin, M.M","CONTACT","18702197991","zhifei.lin.zl3@hengrui.com",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":76,"coordinates":77},"Point",[78,79],113.25,23.11667,{"lat":79,"lon":78},[82,84],{"name":83,"role":63,"phone":36,"phoneExt":36,"email":36},"Jihong Liu",{"name":83,"role":85,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"type":87,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100566381",false,"NCT06654440","A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy","An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies","Inclusion Criteria:\n\n1. Participate in the study voluntarily, sign the informed consent form.\n2. Recurrent or metastatic gynecological malignancies that had failed standard treatments.\n3. At least one measurable lesion (RECIST version 1.1).\n4. ECOG 0\\~ 1.\n5. With adequate organ functions.\n6. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of SHR-A2102，Female participants' HCG must be negative within 72 hours prior to enrollment and must be non-lactating.\n\nExclusion Criteria\n\n1. With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.\n2. Previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. Such as Cutaneous squamous cell carcinoma, cervical carcinoma in situ etc.\n3. Had previously received antibody drug conjugates containing topoisomerase I inhibitors.\n4. Had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration.\n5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.\n6. Had active pulmonary tuberculosis within 1 year prior to enrolment.\n7. Known to be allergic to any of the components of SHR-A2102.\n8. Were not fit to participate in this study by investigator's judgment.","FEMALE","18 Years","75 Years",{"count":98,"type":99},100,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.",[105],"Advanced Gynecological Malignancy","2024-12-09",{"date":108,"type":109},"2024-12-10","ACTUAL",{"date":111,"type":109},"2024-11-15",{"date":113,"type":99},"2026-10-31",{"name":5,"class":6},1]