[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599109":3},{"organization":4,"outcomesModule":7,"designInfo":15,"detailedDescription":11,"studyPopulation":11,"armGroups":21,"interventions":34,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":77,"collaborators":11,"id":79,"slug":11,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":11,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Adverse Event (AE)",null,"Up to 2 years",{"measure":14,"description":11,"timeFrame":12},"Objective response rate (ORR)",{"allocation":16,"interventionModel":17,"interventionModelDescription":11,"primaryPurpose":18,"observationalModel":11,"timePerspective":11,"maskingInfo":19},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":20,"maskingDescription":11,"whoMasked":11},"NONE",[22,30],{"label":23,"type":24,"description":25,"interventionNames":26},"PART 1（phaseⅠ）","EXPERIMENTAL","Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen",[27,28,29],"Biological: ZG005","Drug: Gecacitinib","Biological: Bevacizumab",{"label":31,"type":24,"description":32,"interventionNames":33},"PART 2（phase II）","Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1",[27,28,29],[35,40,45],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"BIOLOGICAL","ZG005","ZG005 20mg\u002Fkg, intravenous infusion(IV), once every 3 weeks (Q3W)",[23,31],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"DRUG","Gecacitinib","Part 1: Cohort A：Gecacitinib is administered continuously until the end of treatment; Cohort B：Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21；Part 2：Gecacitinib for dose exploratory stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose escalation stage.",[23,31],{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"Bevacizumab","Bevacizumab 7.5 mg\u002Fkg，intravenous infusion(IV), once every 3 weeks (Q3W)",[23,31],[50],{"name":51,"affiliation":5,"role":52},"Jason Wu","STUDY_CHAIR",[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Yongsheng Chu","CONTACT","+86-0512-57309965","chuys@zelgen.com",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Zhejiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":69,"coordinates":70},"Point",[71,72],120.16142,30.29365,{"lat":72,"lon":71},[75],{"name":76,"role":56,"phone":11,"phoneExt":11,"email":11},"Hanmei Lou",{"type":78,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100599109",false,"NCT07080216","Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer","A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I\u002FII Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Female 18-75 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Histologically or cytologically confirmed advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\nExclusion Criteria:\n\n* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.","FEMALE","18 Years","75 Years",{"count":89,"type":90},120,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","PHASE2","This is a multicenter, open-label phase I\u002FII study in patients with advanced cervical cancer designed to evaluate the safety, tolerability, and preliminary efficacy of ZG005 in combination with Gecacitinib ± bevacizumab.",[97],"Cervical Cancer","2025-12-30",{"date":100,"type":101},"2026-01-05","ACTUAL",{"date":103,"type":101},"2025-09-23",{"date":105,"type":90},"2027-12",{"name":5,"class":6},1]