[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546118":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":63,"overallOfficials":36,"centralContacts":69,"locations":79,"responsibleParty":98,"collaborators":36,"id":100,"slug":36,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":36,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":36,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":82,"whyStopped":36,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":36},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"DLTs","Dose limiting toxicity","14 days",{"measure":14,"description":15,"timeFrame":16},"AE","Safety and tolerability assessed by incidence and severity of adverse events","up to 1 year",{"measure":18,"description":19,"timeFrame":16},"MTD or MAD","maximum tolerated dose or the maximum administered dose if MTD is not reached",{"measure":21,"description":22,"timeFrame":16},"RP2D","the recommended phase II dose",[24,27,30,33],{"measure":25,"description":26,"timeFrame":16},"ORR","Objective response rate",{"measure":28,"description":29,"timeFrame":16},"PFS","Progression-free Survival",{"measure":31,"description":32,"timeFrame":16},"Cmax","Maximum Plasma Concentration",{"measure":34,"description":35,"timeFrame":16},"T1\u002F2","Half-life",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).",[45,51,55,59],{"label":46,"type":47,"description":48,"interventionNames":49},"Part 1","EXPERIMENTAL","Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, QW IV. Dose extension will be carried out at the selected level.",[50],"Drug: SSGJ-705",{"label":52,"type":47,"description":53,"interventionNames":54},"Part 2","Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q2W IV. Dose extension will be carried out at the selected level.",[50],{"label":56,"type":47,"description":57,"interventionNames":58},"Part 3","Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation includes 6 levels, Q3W IV. Dose extension will be carried out at the selected level.",[50],{"label":60,"type":47,"description":61,"interventionNames":62},"Part 4","Indication extension will be carried out at the selected level，including 3 dosage levels.",[50],[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":36},"DRUG","SSGJ-705","anti-PD-1 and anti-HER2 bispecific antibody",[46,52,56,60],[70,75],{"name":71,"role":72,"phone":73,"phoneExt":36,"email":74},"Jinming Yu, MD,Ph.D","CONTACT","+86-13806406293","sdyujinming@126.com",{"name":76,"role":72,"phone":77,"phoneExt":36,"email":78},"Yuping Sun, MD,Ph.D","+86-13370582181","13370582181@163.com",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":36,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Affiliated Cancer Hospital of Shandong First Medical University","RECRUITING","Jinan","Shandong","China","CN",{"type":88,"coordinates":89},"Point",[90,91],116.99722,36.66833,{"lat":91,"lon":90},[94],{"name":95,"role":72,"phone":96,"phoneExt":36,"email":97},"Zhaowei Li","0531-67626929","sdzlllh803@126.com",{"type":99,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100546118",false,"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.","ALL","18 Years","75 Years",{"count":110,"type":111},180,"ESTIMATED","INTERVENTIONAL",[114],"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.",[117],"Locally Advanced, Recurrent or Metastatic Malignancies",[119],"advanced malignancies","2024-10-16",{"date":122,"type":123},"2024-10-18","ACTUAL",{"date":125,"type":123},"2024-05-30",{"date":127,"type":111},"2027-02",{"name":5,"class":6},1]