[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573838":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":39,"locations":28,"responsibleParty":45,"collaborators":28,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":28,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":28,"enrollmentInfo":56,"targetDuration":28,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":69,"whyStopped":28,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":28},{"fullName":5,"class":6},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Treatment group 1:JSKN003","EXPERIMENTAL","Drug: JSKN003 JSKN003 dose 1",[13],"Drug: JSKN003",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Treatment group 2: Investigator's choice of chemotherapy","ACTIVE_COMPARATOR","Drug: Doxorubicin Doxorubicin dose 2\n\nDrug: Paclitaxel Paclitaxel dose 3\n\nDrug: Topotecan Topotecan dose 4",[19,20,21],"Drug: Doxorubicin","Drug: Paclitaxel","Drug: Topotecan",[23,29,33,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","JSKN003","Experimental drug",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Doxorubicin","Active Comparator",[15],{"type":24,"name":34,"description":31,"armGroupLabels":35,"otherNames":28},"Paclitaxel",[15],{"type":24,"name":37,"description":31,"armGroupLabels":38,"otherNames":28},"Topotecan",[15],[40],{"name":41,"role":42,"phone":43,"phoneExt":28,"email":44},"Lingying Wu, Doctor","CONTACT","8610-87788495","wulingying@csco.org.cn",{"type":46,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100573838","phase-3-jskn003-in-platinum-resistant-relapsed-epithelial-ovarian-cancer-100573838",false,"NCT06751485","JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer","A Randomized, Open-Label, Parallel-Controlled, Multi-center Phase Ⅲ Study of JSKN003 Versus Investigator-Choice Chemotherapy for Platinum-Resistant, Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer","Inclusion Criteria:\n\n* Voluntary participation and written informed consent.\n* ≥18 years;\n* Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n* Confirmed platinum-resistant relapse.\n* According to RECIST 1.1 criteria, there must be at least one measurable lesion in the baseline.\n* Expected survival of more than 3 months.\n* ECOG performance status score of 0 or 1.\n* Adequate organ function.\n* Capable and willing to comply with the study protocol, treatment plan, laboratory tests, and other related study procedures.\n\nExclusion Criteria:\n\n* Primary platinum-refractory disease.\n* Active central nervous system metastases.\n* Uncontrolled pleural effusion.\n* Previous treatment with topoisomerase I inhibitor ADCs.\n* Other malignant tumors within 5 years.\n* Interstitial pneumonia\u002Flung disease requiring systemic corticosteroids or suspected interstitial pneumonia\u002Flung disease.\n* Uncontrolled comorbidities.\n* Toxicity from previous anti-cancer treatments not recovered to CTCAE Grade ≤1.\n* History of allogeneic bone marrow or organ transplantation.\n* Allergic reactions or hypersensitivity to antibody drugs.\n* Conditions affecting study drug treatment safety or compliance, including psychiatric disorders, alcohol abuse, or drug abuse.","FEMALE","18 Years",{"count":57,"type":58},430,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of chemotherapy in patients with platinum-resistant, relapsed epithelial Ovarian, primary peritoneal, or fallopian tube cancer.",[64,65,66],"Ovarian Cancer","Primary Peritoneal","Fallopian Tube Cancers",[68],"JSKN003-306","NOT_YET_RECRUITING","2024-12-27",{"date":72,"type":73},"2024-12-31","ACTUAL",{"date":75,"type":58},"2025-01-15",{"date":77,"type":58},"2027-12-30",{"name":5,"class":6}]