[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534474":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":61,"collaborators":42,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":42,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":42,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":42,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Drug: ZG005 Powder for Injection","Drug: Donafenib Tosilate Tablets",{"label":16,"type":10,"description":17,"interventionNames":18},"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.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ZG005 Powder for Injection","intravenous infusion(IV), once every 3 weeks",[16,9],[26],"ZG005",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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",[16,9],[32],"Donafenib",[34],{"name":35,"affiliation":5,"role":36},"Jason Wu","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Cheng Wei","CONTACT","+86-0512-57309965",null,"weic@zelgen.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The Second Affiliated Hospital of Army Medical University","RECRUITING","Chongqing","Chongqing Municipality","China","CN",{"type":53,"coordinates":54},"Point",[55,56],106.55771,29.56026,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":42,"phoneExt":42,"email":42},"Bo Zhu",{"type":62,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100534474","phase-1-a-study-of-zg005-combined-with-donafenib-in-patients-with-advanced-solid-tumor-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":74,"type":75},130,"ESTIMATED","INTERVENTIONAL",[78,79],"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.",[82],"Solid Tumor","2024-06-13",{"date":85,"type":86},"2024-06-14","ACTUAL",{"date":88,"type":86},"2024-05-10",{"date":90,"type":75},"2026-05",{"name":5,"class":6},1]