[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612787":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":49,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":24,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":24,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Dose Escalation","EXPERIMENTAL","A rapid titration followed by the traditional \"3 + 3\" design will be used for dose escalation: rapid titration is applied to the first cohort, and the conventional \"3 + 3\" method is used for all subsequent cohorts. Dose escalation is planned to proceed through the following dose levels: 0.5 mg, 1.5 mg, 5.0 mg, 15.0 mg, 30.0 mg, 60.0 mg, and 100.0 mg. The initial dosing frequency is set at once every two weeks (Q2W).",[13],"Biological: ZG006",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Dose Expansion","Based on the RP2D identified in the Part 1 dose-escalation study of ZGGS34, expansion cohorts will be enrolled distinct solid-tumor populations to further evaluate the preliminary efficacy and safety of the selected ZGGS34 monotherapy dose.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","ZG006","ZG006 will be administered as an intravenous (IV) infusion.",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Ning Li","Henan Cancer Hospital","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Shuangyu Jia","CONTACT","18039230612","jiasy@zelgen.com",[37],{"facility":28,"status":38,"city":39,"state":40,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":24},"RECRUITING","Zhengzhou","Henan","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.64861,34.75778,{"lat":47,"lon":46},{"type":50,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100612787","phase-1-study-of-zggs34-in-participants-with-advanced-solid-tumors-100612787",false,"NCT07258121","Study of ZGGS34 in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Dose Escalation and Cohort Expansion Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZGGS34 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years old.\n* Archived tumor tissue within 24 months or fresh biopsy specimens must be provided for detection of MUC17 expression, and with positive MUC17 results required.\n* Subjects in different study parts need to meet the following requirements:\n\nPart 1: Dose Escalation Study：Histologically or cytologically confirmed advanced solid tumors who have failed standard treatment or no standard treatment available, or were intolerant to standard treatments.\n\nPart 2: Cohort Expansion Study：Cohort 1 (Gastric cancer): Previously received at least one line systematic treatment and failed; HER2 status negative. Cohort 2 (Pancreatic cancer): Previously received at least one line systematic treatment and failed. Cohort 3 (Colorectal cancer): Previously received at least one line systematic treatment and failed; If patients with MSI-H\u002FdMMR, prior PD-1 therapy is required. Cohort 4: Other patients with advanced solid tumors who have failed standard treatment or have no standard treatment available.\n\nExclusion Criteria:\n\n* Patients having received any of the following treatments: Prior combination or sequential use of drugs targeting anti-MUC17 (including investigational drugs);Chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and biological targeted medicines ≤ 4 weeks before the first dose. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks before the first dose; Systemic immunosuppressive medications, such as corticosteroid within 14 days prior to the first dose; Use of any live or live attenuated vaccines against viral infections within 4 weeks of first dose.\n* The investigator considers the subject unsuitable for enrollment in this clinical study for any other reason.","ALL","18 Years","75 Years",{"count":62,"type":63},400,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE1","PHASE2","This is a multicenter, open-label Phase 1\u002F2 study in participants with advanced solid tumors. The study consists of two parts: Part 1 is a dose-escalation phase to evaluate the safety and tolerability of ZGGS34 in advanced solid tumor participants; Part 2 is a cohort-expansion phase to assess the efficacy and safety of ZGGS34 (± chemotherapy) in selected MUC17-positive advanced solid tumor participants.",[70],"Solid Tumor","2026-04-27",{"date":73,"type":74},"2026-04-28","ACTUAL",{"date":76,"type":74},"2025-12-31",{"date":78,"type":63},"2028-12",{"name":5,"class":6},1]