[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618834":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"JSKN016 Q2W + D-0502","EXPERIMENTAL",null,[13,14],"Drug: JSKN016 Q2W","Drug: D-0502",{"label":16,"type":10,"description":11,"interventionNames":17},"JSKN016 Q3W + D-0502",[18,14],"Drug: JSKN016 Q3W",[20,25,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","JSKN016 Q2W","4 mg\u002Fkg, intravenous infusion, every 2 weeks",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"JSKN016 Q3W","4 mg\u002Fkg, intravenous infusion, every 3 weeks",[16],{"type":21,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"D-0502","200 mg, oral, once daily",[9,16],[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Xiaowen Tang","CONTACT","+86-512-62850800","xiaowentang@alphamabonc.com",[40],{"facility":41,"status":11,"city":42,"state":11,"zip":11,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fudan University Shanghai Cancer center","Shanghai","China","CN",{"type":46,"coordinates":47},"Point",[48,49],121.45806,31.22222,{"lat":49,"lon":48},[52],{"name":53,"role":36,"phone":54,"phoneExt":11,"email":55},"Jian Zhang","+86-21-64175590","syner2000@163.com",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100618834","phase-1-jskn016-in-combination-with-d-0502-for-locally-advanced-or-metastatic-hr-positive-her2-negative-breast-cancer-100618834",false,"NCT07336771","JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer","A Multicenter, Open-Label, Phase Ib\u002FII Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer\n* HR-positive defined as ER and\u002For PR ≥1% by IHC\n* HER2-negative per ASCO\u002FCAP guidelines\n* At least one measurable extracranial lesion per RECIST v1.1\n* ECOG performance status 0-1\n* Prior progression on CDK4\u002F6 inhibitor plus endocrine therapy\n* Adequate organ and cardiac function\n* Postmenopausal women, or premenopausal women receiving ovarian function suppression\n\nExclusion Criteria:\n\n* Active or untreated CNS metastases\n* Prior treatment with ADCs containing topoisomerase I inhibitor payloads\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled cardiovascular disease or active infection\n* Prior malignancy within 5 years (with specific exceptions)\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This is a multicenter, open-label, Phase Ib\u002FII randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4\u002F6 inhibitor-based endocrine therapy.\n\nApproximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.",[76,77],"Metastatic Breast Cancer","Locally Advanced Breast Cancer (LABC)","NOT_YET_RECRUITING","2026-01-04",{"date":81,"type":82},"2026-01-13","ACTUAL",{"date":84,"type":69},"2026-01",{"date":86,"type":69},"2028-06",{"name":5,"class":6},1]