[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634874":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":31,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":63,"collaborators":13,"id":65,"slug":13,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":13,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":13,"enrollmentInfo":73,"targetDuration":13,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":90,"whyStopped":13,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Kivu Bioscience Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To determine Maximum tolerated dose (MTD)","Number of participants with treatment emergent adverse events as assessed by CTCAE Version 6.0.","up to 18 months",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21,27],{"label":22,"type":23,"description":24,"interventionNames":25},"Dose Finding","EXPERIMENTAL","Participants will be treated with KIVU-305 in multiple ascending cohorts",[26],"Drug: KIVU-305",{"label":28,"type":23,"description":29,"interventionNames":30},"Dose Expansion","Participants will be treated with the Recommended Dose for Expansion from Dose Finding.",[26],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":13},"DRUG","KIVU-305","KIVU-305 will be administered IV .",[28,22],[38],{"name":39,"affiliation":40,"role":41},"Louie Naumovski, MD, PhD","Kivu Bioscience","STUDY_CHAIR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":13,"email":47},"Kivu Bioscience (US) US","CONTACT","+1 650.606.5170","KIVU30501@kivubioscience.com",{"name":49,"role":45,"phone":50,"phoneExt":13,"email":47},"Kivu Bioscience (AUS) AUS","+6 187.223.0122",[52],{"facility":53,"status":13,"city":54,"state":55,"zip":13,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":13},"Kivu Trial Site","Sydney","Australia","AU",{"type":58,"coordinates":59},"Point",[60,61],151.20732,-33.86785,{"lat":61,"lon":60},{"type":64,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"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":74,"type":75},76,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Solid Tumors",[83,84,85,86,87,88,89],"CEACAM5","ADC","Antibody drug conjugate","KIVU305","Colorectal cancer","CRC","Phase 1","NOT_YET_RECRUITING","2026-04-16",{"date":93,"type":94},"2026-04-22","ACTUAL",{"date":96,"type":75},"2026-06",{"date":98,"type":75},"2029-12",{"name":5,"class":6},1]