Recruiting
Phase 1

KAN-004

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT07196410

Conditions

Colitis

Diarrhea Caused by Antitumor Drugs

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KAN-004

Study Details

Brief summary:

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

Conditions

Colitis

Diarrhea Caused by Antitumor Drugs

Study ID

NCT07196410

Start date

Mar 1, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with steroid-naïve irColitis

Participants with non-steroid refractory irColitis

Interventions

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

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004 [ Time Frame: 6 weeks of treatment ]

Central Contacts and Locations

Central contacts

Wiam Belkaid, PhD

514-836-3273wiam.belkaid.chum@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0A9

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-13.