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Recruiting

NCT Number: NCT07196410

KAN-004 for Immune-Related Diarrhea or Colitis

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

Recruiting

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Key information

Conditions

Colitis Colonic Diseases Diarrhea Caused by Antitumor Drugs Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 0A9, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

KAN-004

Biological

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

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004

    Time frame: 6 weeks of treatment

    Proportion of participants with non-steroid refractory irColitis experiencing adverse events as measured by CTCAE v5.

Study contacts

Contact information is provided by the study sponsor or research team.

Wiam Belkaid, PhD

CONTACT

[email protected]

514-836-3273

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Sep 29, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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