[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642580":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":30,"studyPopulation":23,"armGroups":31,"interventions":44,"overallOfficials":23,"centralContacts":57,"locations":67,"responsibleParty":86,"collaborators":23,"id":88,"slug":23,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":23,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":23,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":70,"whyStopped":23,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"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},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE","This study includes 2 Parts: Part 1 (SSGJ-705 Plus SSGJ-612 for advanced cancer that have failed standard treatment), and Part 2 (SSGJ-705 or SSGJ-705 Plus SSGJ-612 in combination with chemotherapy for previously untreated advanced gastric cancer).",[32,39],{"label":33,"type":34,"description":35,"interventionNames":36},"Part 1","EXPERIMENTAL","advanced cancer that have failed standard treatment",[37,38],"Drug: SSGJ-705","Drug: SSGJ-612",{"label":40,"type":34,"description":41,"interventionNames":42},"Part 2","previously untreated advanced gastric cancer",[38,43],"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 and anti-HER2 bispecifc antibody",[33],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"SSGJ-612","anti-HER2 antibody",[33,40],{"type":46,"name":55,"description":55,"armGroupLabels":56,"otherNames":23},"SSGJ-705 combined with chemotherapy",[40],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":23,"email":62},"Jieer Ying, M.D.","CONTACT","+86-13858195803","hzyingjieer@163.com",{"name":64,"role":60,"phone":65,"phoneExt":23,"email":66},"Meifang Zheng, M.D.","+86-15258894828","794998553@qq.com",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":23,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Zhejiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":76,"coordinates":77},"Point",[78,79],120.16142,30.29365,{"lat":79,"lon":78},[82],{"name":83,"role":60,"phone":84,"phoneExt":23,"email":85},"Feiyan Li","0571-88122482","lify1697@zjcc.org.cn",{"type":87,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100642580",false,"NCT07646626","SSGJ-705 Plus SSGJ-612 ± Chemotherapy in Advanced HER2-Expressing Solid Tumors","A Phase II Study of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in 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 Colorectal adenocarcinoma (CRC), Urothelial Cancer (UC), Breast Cancer (BC), Biliary Tract Carcinoma(BTC), Gastric\u002FGastroesophageal Junction Cancer （G\u002FGEJC) , etc.\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） v6. 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. 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":98,"type":99},150,"ESTIMATED","INTERVENTIONAL",[102],"PHASE2","This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Plus SSGJ-612 ± Chemotherapy in patients with advanced HER2-Expressing Solid Tumors.",[105],"Locally Advanced (Unresectable) or Metastatic Solid Tumors",[107],"advanced malignancies","2026-06-08",{"date":110,"type":111},"2026-06-15","ACTUAL",{"date":113,"type":99},"2026-07-31",{"date":115,"type":99},"2028-10-31",{"name":5,"class":6},1]