[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-recurrent-or-metastatic-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-recurrent-or-metastatic-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100594634","phase-2-ssgj-705-monotherapy-and-combination-therapy-in-advanced-her2-expressing-solid-tumors-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":20,"type":21},340,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Locally Advanced, Recurrent or Metastatic Malignancies",[29],"advanced malignancies","RECRUITING","2025-08-01",{"date":33,"type":34},"2025-08-03","ACTUAL",{"date":36,"type":34},"2025-07-30",{"date":38,"type":21},"2027-12-12",{"name":40,"class":41},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100546118","phase-1-a-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-ssgj-705-monotherapy-in-patients-with-advanced-malignant-tumors-100546118","NCT06390774","A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Males and\u002For females over age 18\n2. Histologically and\u002For cytologically documented local advanced or recurrent or metastatic malignancies\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>3 months.\n5. Signed informed consent form.\n6. Must have adequate organ function.\n\nExclusion Criteria:\n\n1. Any remaining AEs \\> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.\n2. Pregnant or nursing women or women\u002Fmen who are ready to give birth\n3. Symptomatic central nervous system metastasis.\n4. Allergy to other antibody drugs or any excipients in the study drugs.\n5. Severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy.\n6. Participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) .\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":51,"type":21},180,[53],"PHASE1","This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.",[27],[29],"2024-10-16",{"date":59,"type":34},"2024-10-18",{"date":61,"type":34},"2024-05-30",{"date":63,"type":21},"2027-02",{"name":65,"class":41},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd."]