KAN-004 for Immune-Related Diarrhea or Colitis

Recruiting now · Phase 1

Conditions studied: Colitis, Diarrhea Caused by Antitumor Drugs

In brief

The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.

Key facts

Study ID

NCT07196410

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

21

Starts

2026-03-01

Expected to finish

2030-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.