KAN-004 for Immune-Related Diarrhea or Colitis

NCT ID: NCT07196410

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2030-12-31

Brief Summary

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

Detailed Description

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Conditions

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Colitis Diarrhea Caused by Antitumor Drugs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with steroid-naïve irColitis

Participants with non-steroid refractory irColitis

Group Type EXPERIMENTAL

KAN-004

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arielle Elkrief, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Universite de Montreal (CHUM)

Locations

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Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Anna S Perez

Role: CONTACT

514-890-8000 ext. 31326

Wiam Belkaid, PhD

Role: CONTACT

Other Identifiers

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MP-02-2026-12952 (AE-KAN-004)

Identifier Type: -

Identifier Source: org_study_id

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