[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634874":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":51,"collaborators":24,"id":53,"slug":24,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":24,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":24,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":78,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Kivu Bioscience Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Finding","EXPERIMENTAL","Participants will be treated with KIVU-305 in multiple ascending cohorts",[13],"Drug: KIVU-305",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Expansion","Participants will be treated with the Recommended Dose for Expansion from Dose Finding.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","KIVU-305","KIVU-305 will be administered IV .",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Louie Naumovski, MD, PhD","Kivu Bioscience","STUDY_CHAIR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Kivu Bioscience (US) US","CONTACT","+1 650.606.5170","KIVU30501@kivubioscience.com",{"name":37,"role":33,"phone":38,"phoneExt":24,"email":35},"Kivu Bioscience (AUS) AUS","+6 187.223.0122",[40],{"facility":41,"status":24,"city":42,"state":43,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Kivu Trial Site","Sydney","Australia","AU",{"type":46,"coordinates":47},"Point",[48,49],151.20732,-33.86785,{"lat":49,"lon":48},{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100634874",false,"NCT07545356","A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1 Dose-Finding and Dose Optimization-Expansion Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Pathologically or histologically documented diagnosis of advanced \u002F metastatic solid tumor malignancy that is resistant to standard therapy or for which no standard therapy is available\n* Adequate bone marrow, kidney, and liver function\n* Measurable disease using RECIST v1.1\n* ECOG 0 or 1\n* Life expectancy ≥ 3 months\n\nExclusion Criteria:\n\n* Prior treatment with any ADC with a topoisomerase 1 inhibitor payload\n* Prior treatment with any CEACAM5 targeted therapy\n* Uncontrolled cardiovascular disease\n* Uncontrolled active Hepatitis B, Hepatitis C, or HIV infection\n* History of interstitial lung disease\n* Major surgery, radiation therapy, or systemic anti-cancer within 3 weeks of study treatment start","ALL","18 Years",{"count":62,"type":63},76,"ESTIMATED","INTERVENTIONAL",[66],"PHASE1","This is a 2-part, first-in-human, open-label study to determine the safety, tolerability and preliminary efficacy of KIVU-305, a CEACAM5-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.",[69],"Solid Tumors",[71,72,73,74,75,76,77],"CEACAM5","ADC","Antibody drug conjugate","KIVU305","Colorectal cancer","CRC","Phase 1","NOT_YET_RECRUITING","2026-04-16",{"date":81,"type":82},"2026-04-22","ACTUAL",{"date":84,"type":63},"2026-06",{"date":86,"type":63},"2029-12",{"name":5,"class":6},1]