[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594933":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":40,"locations":46,"responsibleParty":63,"collaborators":65,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":23,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":49,"whyStopped":23,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","IBI343 Combined with Sintilimab Plus SOX",[13,14,15,16],"Drug: IBI343","Drug: Sintilimab","Drug: Oxaliplatin","Drug: S-1",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","IBI343","Subjects in the phase 1b stage will receive IBI343 3\u002F4.5\u002F6mg\u002Fkg intravenous infusion (IV) D1 Q3W in 3-week cycles.\n\nSubjects in the phase 2 stage will receive IBI343 RP2D intravenous IV D1 Q3W in 3-week cycles.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Sintilimab","Subjects will receive sintilimab 200mg IV D1 Q3W in 3-week cycles.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Oxaliplatin","Subjects will receive oxaliplatin 130mg\u002Fm2 IV D1 Q3W in 3-week cycles.",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"S-1","Subjects will receive S-1 40-60mg BID PO D1-14 Q3W in 3-week cycles.",[9],[37],{"name":38,"affiliation":5,"role":39},"Min Shi, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":23,"email":45},"Ruijin Hospital, Shanghai Jiao Tong University School of Medic","CONTACT","021-64370045","sm11998@rjh.com.cn",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":56,"coordinates":57},"Point",[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62],{"name":48,"role":43,"phone":44,"phoneExt":23,"email":45},{"type":64,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[66],{"name":48,"class":6},"100594933","phase-1-ibi343-combined-with-sintilimab-plus-chemotherapy-in-gastric-cancer-100594933",false,"NCT07025889","IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer","IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)","Inclusion Criteria:\n\n* 1\\. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.\n\n  2\\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.\n\n  3\\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric\u002Fgastroesophageal junction (G\u002FGEJ AC).\n\n  4\\. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n\nExclusion Criteria:\n\n* 1\\. Has HER2-positive (defined as immunohistochemistry \\[IHC\\] 3+, or IHC 2+ and positive by in situ hybridization) disease.\n\n  2\\. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.\n\n  3\\. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).","ALL","18 Years","75 Years",{"count":78,"type":79},55,"ESTIMATED","INTERVENTIONAL",[82,83],"PHASE1","PHASE2","This is a Single-arm, Open-label, Phase 1b\u002F2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",[86],"Gastric Cancer",[86,88,25],"IBI 343","2026-08-17",{"date":91,"type":92},"2026-08-18","ACTUAL",{"date":94,"type":92},"2025-06-02",{"date":96,"type":79},"2028-06",{"name":5,"class":6},1]