RecruitingPhase 1NCT07196410
KAN-004 for Immune-Related Diarrhea or Colitis
A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
21 participants
Start Date
Mar 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Diagnosis of solid tumor treated with immune checkpoint inhibitor (≥1 cycle, ≤180 days since last cycle).
- Clinical diagnosis of irColitis (CTCAE >grade 2).
- Age ≥18 years
- Able to ingest capsules.
- Consent to provide blood and stool samples.
- Accessible for treatment and follow-up.
- Agreement to use highly effective contraception if of childbearing potential.
Exclusion Criteria7
- Prior/concurrent malignancy that could interfere with safety/efficacy assessment.
- Colostomy.
- Prior diagnosis of malabsorption.
- Untreated chronic hepatitis B or C.
- Solid organ transplant recipients.
- HIV-positive status.
- Pregnancy or breastfeeding.
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Interventions
BIOLOGICALKAN-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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07196410
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