[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534474":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":39,"overallOfficials":53,"centralContacts":57,"locations":63,"responsibleParty":80,"collaborators":20,"id":82,"slug":20,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":20,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":20,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":20,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR)","The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.","Up to 2 years",{"measure":14,"description":15,"timeFrame":12},"Dose Limiting Toxicity (DLT)","A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause",[17],{"measure":18,"description":19,"timeFrame":12},"Duration of response (DOR)","Time from the first evaluated CR or PR until PD or death from any cause",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28,35],{"label":29,"type":30,"description":31,"interventionNames":32},"Dose Exploration","EXPERIMENTAL","The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.",[33,34],"Drug: ZG005 Powder for Injection","Drug: Donafenib Tosilate Tablets",{"label":36,"type":30,"description":37,"interventionNames":38},"Dose Expansion","The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.",[33,34],[40,47],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","ZG005 Powder for Injection","intravenous infusion(IV), once every 3 weeks",[36,29],[46],"ZG005",{"type":41,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Donafenib Tosilate Tablets","The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage",[36,29],[52],"Donafenib",[54],{"name":55,"affiliation":5,"role":56},"Jason Wu","STUDY_CHAIR",[58],{"name":59,"role":60,"phone":61,"phoneExt":20,"email":62},"Cheng Wei","CONTACT","+86-0512-57309965","weic@zelgen.com",[64],{"facility":65,"status":66,"city":67,"state":68,"zip":20,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"The Second Affiliated Hospital of Army Medical University","RECRUITING","Chongqing","Chongqing Municipality","China","CN",{"type":72,"coordinates":73},"Point",[74,75],106.55771,29.56026,{"lat":75,"lon":74},[78],{"name":79,"role":60,"phone":20,"phoneExt":20,"email":20},"Bo Zhu",{"type":81,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100534474",false,"NCT06239298","A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor","A Multi-center, Open, Dose Exploration and Dose Expansion Phase I\u002FII Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.","ALL","18 Years","70 Years",{"count":92,"type":93},130,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE1","PHASE2","This is a Multi-center, Open-labe, Phase I\u002FII Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.",[100],"Solid Tumor","2024-06-13",{"date":103,"type":104},"2024-06-14","ACTUAL",{"date":106,"type":104},"2024-05-10",{"date":108,"type":93},"2026-05",{"name":5,"class":6},1]