[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613208":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":140,"collaborators":142,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":32,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":32,"enrollmentInfo":154,"targetDuration":32,"studyType":157,"phases":158,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"DualityBio Inc.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"DB-1324 Phase 1 Dose escalation","EXPERIMENTAL","Enrolled Subjects will receive a single-dose of DB-1324 at different Dose Level or different dose regimen",[13],"Drug: DB-1324",{"label":15,"type":10,"description":16,"interventionNames":17},"DB-1324 Phase 1 Backfill","Participants with GI cancers who have received no more than 3 prior lines of systemic therapy may be backfilled at the selected dose regimens to further explore the safety, efficacy, PK, and pharmacodynamics of DB-1324.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"DB-1324 Phase 1 Dose Expansion","Two or more appropriate dose regimens of DB-1324, determined from the emerging dose escalation (and backfill) data, will be explored for preliminary efficacy and safety of DB-1324.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"DB-1324 Phase 2","Phase 2 will consist of one or more cohorts intended to confirm early signals of efficacy identified in Phase 1.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","DB-1324","Administered I.V.",[15,19,9,23],null,[34],{"name":35,"affiliation":5,"role":36},"Lily Hu","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Zhaochuan Wang","CONTACT","4123279868","zhaochuan.wang@dualitybiologics.com",{"name":44,"role":40,"phone":32,"phoneExt":32,"email":45},"Yuanyuan Sun","yuanyuan.sun@dualitybiologics.com",[47,61,71,81,91,103,113,123,134],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":32},"USA05-0","RECRUITING","Port Saint Lucie","Florida","34952","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-80.35033,27.29393,{"lat":59,"lon":58},{"facility":62,"status":49,"city":63,"state":64,"zip":65,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":70,"contacts":32},"USA02-0","Grand Rapids","Michigan","49546",{"type":56,"coordinates":67},[68,69],-85.66809,42.96336,{"lat":69,"lon":68},{"facility":72,"status":49,"city":73,"state":74,"zip":75,"country":53,"countryCode":54,"cosmosGeoPoint":76,"geoPoint":80,"contacts":32},"USA01-0","Huntersville","North Carolina","28078",{"type":56,"coordinates":77},[78,79],-80.84285,35.41069,{"lat":79,"lon":78},{"facility":82,"status":49,"city":83,"state":84,"zip":85,"country":53,"countryCode":54,"cosmosGeoPoint":86,"geoPoint":90,"contacts":32},"USA03-0","Cincinnati","Ohio","45219",{"type":56,"coordinates":87},[88,89],-84.51439,39.12711,{"lat":89,"lon":88},{"facility":92,"status":49,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":32},"AUS02-0","Randwick","New South Wales","2031","Australia","AU",{"type":56,"coordinates":99},[100,101],151.24895,-33.91439,{"lat":101,"lon":100},{"facility":104,"status":49,"city":105,"state":106,"zip":107,"country":96,"countryCode":97,"cosmosGeoPoint":108,"geoPoint":112,"contacts":32},"AUS03-0","South Brisbane","Queensland","4101",{"type":56,"coordinates":109},[110,111],153.02049,-27.48034,{"lat":111,"lon":110},{"facility":114,"status":49,"city":115,"state":116,"zip":117,"country":96,"countryCode":97,"cosmosGeoPoint":118,"geoPoint":122,"contacts":32},"AUS01-0","Nedlands","Western Australia","6009",{"type":56,"coordinates":119},[120,121],115.8073,-31.98184,{"lat":121,"lon":120},{"facility":124,"status":49,"city":125,"state":32,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":32},"CHN01-0","Beijing","100142","China","CN",{"type":56,"coordinates":130},[131,132],116.39723,39.9075,{"lat":132,"lon":131},{"facility":135,"status":49,"city":125,"state":32,"zip":136,"country":127,"countryCode":128,"cosmosGeoPoint":137,"geoPoint":139,"contacts":32},"CHN04-0","102206",{"type":56,"coordinates":138},[131,132],{"lat":132,"lon":131},{"type":141,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[143],{"name":144,"class":6},"GlaxoSmithKline","100613208","phase-1-a-study-of-db-1324-in-advancedmetastatic-gastrointestinal-tumors-100613208",false,"NCT07263594","A Study of DB-1324 in Advanced\u002FMetastatic Gastrointestinal Tumors","A Phase 1\u002F2, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1324 in Participants With Advanced\u002FMetastatic Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Pathologically documented advanced\u002Funresectable, or metastatic GI tumor.\n2. Have relapsed or progressed on or after standard systemic treatments, or are intolerant to standard treatment, or for which no standard treatment is available.\n3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in RECIST v1.1.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an ECOG PS of 0-1.\n6. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.\n7. Has adequate organ functions within 7 days prior to Day 1 of Cycle 1.\n8. Has an adequate treatment washout period before Day 1 of Cycle 1.\n9. Participants are willing to provide archived tumor tissue or undergo a tumor biopsy for the measurement of CDH17 levels and other biomarkers.\n10. Other protocol-defined Inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Prior treatment with CDH17 targeted therapy.\n2. Prior treatment with ADC with topoisomerase I inhibitor.\n3. Has chronic enteritis or inflammatory bowel disease. Or has clinically significant bleeding of GI tract or adjacent organs within 1 month prior to the first dose of study treatment. Or has clinically significant obstruction and\u002For perforation and\u002For fistulae (including prior GI fistula operation) of GI tract or adjacent tissues within 6 months prior to the first dose of study treatment.\n4. Uncontrolled or significant cardiovascular disease.\n5. Has a medical history of cerebrovascular accident including transient ischemic attack within 6 months before enrollment.\n6. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, or has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n7. Have a lung-specific intercurrent clinically significant illness.\n8. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n9. Has clinically active brain metastases.\n10. Has unresolved toxicities from previous anticancer therapy.\n11. Other protocol-defined Exclusion criteria apply.","ALL","18 Years",{"count":155,"type":156},127,"ESTIMATED","INTERVENTIONAL",[159,160],"PHASE1","PHASE2","This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.",[163],"Gastrointestinal Cancer",[165],"Gastrointestinal Tumors, DB-1324","2026-05-19",{"date":168,"type":169},"2026-05-22","ACTUAL",{"date":171,"type":169},"2026-01-20",{"date":173,"type":156},"2028-12",{"name":5,"class":6},9]