[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594634":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":44,"overallOfficials":23,"centralContacts":58,"locations":68,"responsibleParty":87,"collaborators":23,"id":89,"slug":23,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":23,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":23,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":71,"whyStopped":23,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":23},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Objective response rate (ORR)","The primary efficacy end point","12 months",{"measure":14,"description":15,"timeFrame":12},"Incidence of Treatment-Emergent Adverse Events","The primary safety end point",{"measure":17,"description":15,"timeFrame":12},"Severity of Treatment-Emergent Adverse Events",[19],{"measure":20,"description":21,"timeFrame":22},"Progression-Free-Survival (PFS)","The secondary efficacy end point","24 months",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"NA","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Part 1","EXPERIMENTAL","advanced gastric cancer and breast cancer that have failed standard treatment",[37],"Drug: SSGJ-705",{"label":39,"type":34,"description":40,"interventionNames":41},"Part 2","previously untreated advanced gastric cancer and lung cancer",[42,43],"Drug: PD-1\u002FL1 inhibitor combined with chemotherapy","Drug: SSGJ-705 combined with chemotherapy",[45,50,54],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":23},"DRUG","SSGJ-705","anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody",[33],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"PD-1\u002FL1 inhibitor combined with chemotherapy","Immune checkpoint inhibitors",[39],{"type":46,"name":55,"description":56,"armGroupLabels":57,"otherNames":23},"SSGJ-705 combined with chemotherapy","anti-PD-1 and anti-HER2 bispecifc antibody",[39],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":23,"email":63},"Jieer Ying, M.D","CONTACT","86-13858195803","hzyingjieer@163.com",{"name":65,"role":61,"phone":66,"phoneExt":23,"email":67},"Meifang Zheng, M.D.","86-15258894828","794998553@qq.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":23,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Zhejiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":77,"coordinates":78},"Point",[79,80],120.16142,30.29365,{"lat":80,"lon":79},[83],{"name":84,"role":61,"phone":85,"phoneExt":23,"email":86},"Feiyan Li","0571-88122482","lify1697@zjcc.org.cn",{"type":88,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100594634",false,"NCT07022002","SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors","A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n* Males and\u002For females over age 18.\n* Histologically and\u002For cytologically documented local advanced or metastatic non-Small Cell Lung Cancer（NSCLC），Breast Cancer（BC）or Gastric\u002FGastroesophageal Junction Cancer （G\u002FGEJC).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival \\>3 months.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Any remaining adverse events (AEs) \\> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.\n* Pregnant or nursing women or women\u002Fmen who are ready to give birth.\n* symptomatic central nervous system metastasis.\n* Allergy to other antibody drugs or any excipients in the study drugs.\n* Inadequate organ or bone marrow function.","ALL","18 Years","75 Years",{"count":99,"type":100},340,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.",[106],"Locally Advanced, Recurrent or Metastatic Malignancies",[108],"advanced malignancies","2025-08-01",{"date":111,"type":112},"2025-08-03","ACTUAL",{"date":114,"type":112},"2025-07-30",{"date":116,"type":100},"2027-12-12",{"name":5,"class":6},1]