[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655603":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":11,"armGroups":38,"interventions":45,"overallOfficials":11,"centralContacts":51,"locations":11,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":11},{"fullName":5,"class":6},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with adverse events (AEs)",null,"From the first dose of 3SC009 until 28 days after last dose of 3SC009",{"measure":14,"description":11,"timeFrame":15},"Number of participants with DLTs","At the end of Cycle 1 (up to 14 days)",[17,20,22,25,27,29],{"measure":18,"description":11,"timeFrame":19},"The blood concentration of 3SC009","From first dose of 3SC009 through 28 days after last dose of 3SC009",{"measure":21,"description":11,"timeFrame":19},"The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)",{"measure":23,"description":11,"timeFrame":24},"Objective response rate (ORR)","Up to 2 years",{"measure":26,"description":11,"timeFrame":24},"Disease control rate (DCR)",{"measure":28,"description":11,"timeFrame":24},"Progression-free survival (PFS)",{"measure":30,"description":11,"timeFrame":24},"Overall survival (OS)",{"allocation":32,"interventionModel":33,"interventionModelDescription":11,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":11},"NONE","3SC009 is a bispecific antibody targeting EpCAM and CD47. This study is a study of 3SC009 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of 3SC009. The first Part is Q2W and Second part is QW. Each part will assess the efficacy and safety of the preset several dose levels of 3SC009 in advanced Solid Tumors.",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"different doses of 3SC009","EXPERIMENTAL","different dose levels of 3SC009",[44],"Drug: 3SC009",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"DRUG","3SC009","A CD47\u002FEpCAM bispecific antibody",[40],[52],{"name":53,"role":54,"phone":55,"phoneExt":11,"email":56},"Yongchang Zhang","CONTACT","13873123436","zhangyongchang@csu.edu.cn",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655603","phase-1-phase-i-clinical-study-to-evaluate-the-safety-and-efficacy-of-3sc009-monotherapy-for-patients-with-advanced-solid-tumors-100655603",false,"NCT07815002","Phase I Clinical Study to Evaluate the Safety and Efficacy of 3SC009 Monotherapy for Patients With Advanced Solid Tumors","Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of 3SC009 Monotherapy for Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Males and\u002For females over age 18\n2. Histologically and\u002For cytologically documented advanced or metastatic Solid Tumors .\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>=3 months.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease.\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI CTCAE\\] v.6.0).\n3. Inadequate organ or bone marrow function.\n4. Pregnant or breast-feeding woman.\n5. Known allergies, hypersensitivity, or intolerance to 3SC009 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years","75 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study includes two parts, different part has different administration frequencies of 3SC009.",[77],"Advanced Solid Tumors Patients",[79],"Solid Tumors","NOT_YET_RECRUITING","2026-09-10",{"date":83,"type":84},"2026-09-11","ACTUAL",{"date":86,"type":71},"2026-09-30",{"date":88,"type":71},"2028-09-30",{"name":5,"class":6}]