Status:
NOT_YET_RECRUITING
KAN-004 for Immune-Related Diarrhea or Colitis
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Colitis
Diarrhea Caused by Antitumor Drugs
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT07196410
Start Date
October 1 2025
End Date
December 31 2030
Last Update
September 29 2025
Active Locations (1)
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1
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 0A9