KAN-004 for Immune-Related Diarrhea or Colitis | NCT07196410

Studies
KAN-004 for Immune-Related Diarrhea or Colitis

NCT07196410

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

21Estimated

Phase

Phase 1

Conditions

Colitis
Diarrhea Caused by Antitumor Drugs

Interventions

KAN-004

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2026Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Sep 15, 2025

First Submission Date that Met QC Criteria

Sep 19, 2025

First Posted Date

Sep 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants with steroid-naïve irColitis	Experimental	Participants with non-steroid refractory irColitis	Biological: KAN-004

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wiam Belkaid, PhD	Contact	514-836-3273		wiam.belkaid.chum@ssss.gouv.qc.ca

Overall Officials

Name	Affiliation	Role
Arielle Elkrief, MD	Centre hospitalier de l'Université de Montréal (CHUM)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de l'Universite de Montreal	Recruiting	Montreal	Quebec	H2X 0A9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D003092	Colitis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D003108	Colonic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided