[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603837":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":49,"centralContacts":53,"locations":62,"responsibleParty":128,"collaborators":48,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":48,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":48,"enrollmentInfo":139,"targetDuration":48,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":65,"whyStopped":48,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"DualityBio Inc.","INDUSTRY",[8,14,18,22,26,30,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"DB-1317 Dose Level 1","EXPERIMENTAL","Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 1 on Day 1 of each cycle Q3W",[13],"Drug: DB-1317",{"label":15,"type":10,"description":16,"interventionNames":17},"DB-1317 Dose Level 2","Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 2 on Day 1 of each cycle Q3W",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"DB-1317 Dose Level 3","Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 3 on Day 1 of each cycle Q3W",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"DB-1317 Dose Level 4","Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 4 on Day 1 of each cycle Q3W",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"DB-1317 Dose Level 5","Enrolled Subjects will receive a single-dose of DB-1317 at Dose Level 5 on Day 1 of each cycle Q3W",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"DB-1317 Dose Expansion 1","Subjects with advanced\u002Funresectable, or metastatic Gastric cancer (GC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"DB-1317 Dose Expansion 2","Subjects with advanced\u002Funresectable, or metastatic colorectal cancer (CRC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317",[13],{"label":39,"type":10,"description":40,"interventionNames":41},"DB-1317 Dose Expansion 3","Subjects with advanced\u002Funresectable, or metastatic pancreatic ductal adenocarcinoma (PDAC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1317",[13],[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","DB-1317","Administered I.V.",[31,35,39,9,15,19,23,27],null,[50],{"name":51,"affiliation":5,"role":52},"Lily Hu","STUDY_DIRECTOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":48,"email":58},"Junhua Gao","CONTACT","01067228087","junhua.gao@dualitybiologics.com",{"name":60,"role":56,"phone":48,"phoneExt":48,"email":61},"Michael Sun","michael.sun@dualitybiologics.com",[63,77,87,97,106,116],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":48},"USA04-0","RECRUITING","Los Angeles","California","90025","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-118.24368,34.05223,{"lat":75,"lon":74},{"facility":78,"status":65,"city":79,"state":80,"zip":81,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":86,"contacts":48},"Site USA06-0","Pittsburgh","Pennsylvania","15232",{"type":72,"coordinates":83},[84,85],-79.99589,40.44062,{"lat":85,"lon":84},{"facility":88,"status":65,"city":89,"state":90,"zip":91,"country":69,"countryCode":70,"cosmosGeoPoint":92,"geoPoint":96,"contacts":48},"USA02-0","Houston","Texas","77030",{"type":72,"coordinates":93},[94,95],-95.36327,29.76328,{"lat":95,"lon":94},{"facility":98,"status":65,"city":99,"state":90,"zip":100,"country":69,"countryCode":70,"cosmosGeoPoint":101,"geoPoint":105,"contacts":48},"USA03-0","San Antonio","78229",{"type":72,"coordinates":102},[103,104],-98.49363,29.42412,{"lat":104,"lon":103},{"facility":107,"status":65,"city":108,"state":109,"zip":110,"country":69,"countryCode":70,"cosmosGeoPoint":111,"geoPoint":115,"contacts":48},"USA01","Fairfax","Virginia","22031",{"type":72,"coordinates":112},[113,114],-77.30637,38.84622,{"lat":114,"lon":113},{"facility":117,"status":65,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":48},"AUS01-0","Randwick","New South Wales","2031","Australia","AU",{"type":72,"coordinates":124},[125,126],151.24895,-33.91439,{"lat":126,"lon":125},{"type":129,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100603837","phase-1-a-study-of-db-1317-in-selected-advancedmetastatic-solid-tumors-100603837",false,"NCT07141706","A Study of DB-1317 in Selected Advanced\u002FMetastatic Solid Tumors","A Phase 1a\u002F1b, Multicenter, Open-Label, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1317 in Participants With Selected Advanced\u002FMetastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female adults\n2. Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.\n3. Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.\n4. Has a life expectancy of ≥ 3 months.\n5. Has an ECOG PS of 0-1.\n6. Has LVEF ≥ 50% within 28 days before enrollment.\n7. Is willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of ADAM9 expression level and other biomarkers if no contra-indication.\n8. Male and female participants of reproductive\u002Fchildbearing potential must agree to use adequate contraceptive methods\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ADAM9 targeted therapy.\n2. Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.\n3. Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.\n4. Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.\n5. Has any clinically important abnormalities in rhythm, conduction or morphology of resting ECG\n6. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \\> 470 ms in males and females\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis\n8. Has a lung-specific intercurrent clinically significant illness\n9. Has an uncontrolled infection requiring intravenous injection of antibiotics, antivirals, or antifungals.\n10. Known human immunodeficiency virus (HIV) infection;Chronic, active, or uncontrolled hepatitis B;\n11. Known chronic, active, or uncontrolled hepatitis C\n12. Has clinically significant corneal disease.\n13. Has clinically active brain metastases\n14. Has unresolved toxicities from previous anticancer therapy Concurrent malignancy \\\u003C 3 years.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":140,"type":141},233,"ESTIMATED","INTERVENTIONAL",[144],"PHASE1","This is a multicenter, open-label, multiple-dose, FIH Phase 1a\u002F1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes up to 3 randomized dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.",[147],"Advanced\u002FMetastatic Solid Tumors",[149,150,45],"ADAM9","Solid tumor","2026-04-07",{"date":153,"type":154},"2026-04-09","ACTUAL",{"date":156,"type":154},"2025-09-23",{"date":158,"type":141},"2028-06",{"name":5,"class":6},6]