[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484189":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":55,"interventions":65,"overallOfficials":74,"centralContacts":78,"locations":84,"responsibleParty":103,"collaborators":48,"id":105,"slug":48,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":48,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":48,"studyType":117,"phases":118,"briefSummary":121,"conditions":122,"keywords":48,"overallStatus":87,"whyStopped":48,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":48},[9,13],{"measure":10,"description":11,"timeFrame":12},"Tolerability of ZGGS18","Dose limiting toxicity, number of participants with abnormal laboratory values and\u002For adverse events that are related to treatment","28 days",{"measure":14,"description":15,"timeFrame":16},"Safety of ZGGS18","Number of participants with adverse events\u002Fabnormal laboratory values that are related to treatment","Through study completion, an expected average of 3 years",[18,22,24,26,28,30,32,35,38,40,42,44,46],{"measure":19,"description":20,"timeFrame":21},"Pharmacokinetic characteristics of ZGGS18","Peak Plasma Concentration (Cmax)","Through Phase I study completion, an expected average of 1 year",{"measure":19,"description":23,"timeFrame":21},"Time to maximum concentration (Tmax)",{"measure":19,"description":25,"timeFrame":21},"Clearance (CL\u002FF)",{"measure":19,"description":27,"timeFrame":21},"Area under drug concentration-time curve",{"measure":19,"description":29,"timeFrame":21},"Elimination rate constant (Ke)",{"measure":19,"description":31,"timeFrame":21},"Elimination half-life (t1\u002F2)",{"measure":33,"description":34,"timeFrame":16},"Immunogenicity of ZGGS18","Detection of anti-drug antibodies, if positive, further detection of neutralizing antibodies. Counting the number of patients and incidence of anti-drug antibodies and neutralizing antibodies",{"measure":36,"description":37,"timeFrame":16},"Efficacy of ZGGS18","Objective response rate",{"measure":36,"description":39,"timeFrame":16},"Progression-free survival",{"measure":36,"description":41,"timeFrame":16},"Disease control rate",{"measure":36,"description":43,"timeFrame":16},"Duration of response",{"measure":36,"description":45,"timeFrame":16},"Time to response",{"measure":36,"description":47,"timeFrame":16},"Time to progression",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE",[56,61],{"label":57,"type":58,"description":48,"interventionNames":59},"Dose Escalation","EXPERIMENTAL",[60],"Biological: ZGGS18 for Injection",{"label":62,"type":58,"description":63,"interventionNames":64},"Dose Expansion","Tumor type: colorectal cancer，pancreatic cancer",[60],[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":48},"BIOLOGICAL","ZGGS18 for Injection","0.3 mg\u002Fkg, 1 mg\u002Fkg, 3 mg\u002Fkg, 6 mg\u002Fkg, 10 mg\u002Fkg, 15 mg\u002Fkg and 20 mg\u002Fkgof ZGGS18，intravenous infusion, once every 2 weeks.",[57],{"type":67,"name":68,"description":72,"armGroupLabels":73,"otherNames":48},"Recommended Phase 2 Dose (RP2D) (to be determined) of ZGGS18，intravenous infusion, once every 2 weeks.",[62],[75],{"name":76,"affiliation":5,"role":77},"Jason Wu","STUDY_DIRECTOR",[79],{"name":80,"role":81,"phone":82,"phoneExt":48,"email":83},"Shangdi Ning","CONTACT","+86-0512-57018308","ningsd@zelgen.com",[85],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":94,"coordinates":95},"Point",[96,97],116.39723,39.9075,{"lat":97,"lon":96},[100],{"name":101,"role":81,"phone":48,"phoneExt":48,"email":102},"Jianming Xu","Jianmingxu2014@163.com",{"type":104,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100484189",false,"NCT05584800","Study of ZGGS18 in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). 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