[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608042":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":20,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with steroid-naïve irColitis","EXPERIMENTAL","Participants with non-steroid refractory irColitis",[13],"Biological: KAN-004",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","KAN-004","Each dose of KAN-004 contains a consortium of bacteria isolated from the stool of healthy donors formulated as a powder in a capsule intended for oral administration",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Arielle Elkrief, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Wiam Belkaid, PhD","CONTACT","514-836-3273","wiam.belkaid.chum@ssss.gouv.qc.ca",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":20},"Centre Hospitalier de l'Universite de Montreal","RECRUITING","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":41,"coordinates":42},"Point",[43,44],-73.58781,45.50884,{"lat":44,"lon":43},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100608042","phase-1-kan-004-for-immune-related-diarrhea-or-colitis-100608042",false,"NCT07196410","KAN-004 for Immune-Related Diarrhea or Colitis","A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis","Inclusion Criteria:\n\n* Diagnosis of solid tumor treated with immune checkpoint inhibitor (≥1 cycle, ≤180 days since last cycle).\n* Clinical diagnosis of irColitis (CTCAE \\>grade 2).\n* Age ≥18 years\n* Able to ingest capsules.\n* Consent to provide blood and stool samples.\n* Accessible for treatment and follow-up.\n* Agreement to use highly effective contraception if of childbearing potential.\n\nExclusion Criteria:\n\n* Prior\u002Fconcurrent malignancy that could interfere with safety\u002Fefficacy assessment.\n* Colostomy.\n* Prior diagnosis of malabsorption.\n* Untreated chronic hepatitis B or C.\n* Solid organ transplant recipients.\n* HIV-positive status.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":58,"type":59},21,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.",[65,66],"Colitis","Diarrhea Caused by Antitumor Drugs","2026-04-08",{"date":69,"type":70},"2026-04-13","ACTUAL",{"date":72,"type":70},"2026-03-01",{"date":74,"type":59},"2030-12-31",{"name":5,"class":6},1]