NCT07196410

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
57mo left

Started Mar 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Dec 2030

First Submitted

Initial submission to the registry

September 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

September 15, 2025

Last Update Submit

April 8, 2026

Conditions

ColitisDiarrhea Caused by Antitumor Drugs

Outcome Measures

Primary Outcomes (1)

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

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

    6 weeks of treatment

Study Arms (1)

Participants with steroid-naïve irColitis

EXPERIMENTAL

Participants with non-steroid refractory irColitis

Biological: KAN-004

Interventions

KAN-004BIOLOGICAL

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

Participants with steroid-naïve irColitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Colitis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Arielle Elkrief, MD

    Centre Hospitalier de l'Universite de Montreal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiam Belkaid, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 29, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CA(1)