ColitisPhase 1NCT07196410
KAN-004 for Immune-Related Diarrhea or Colitis
A Phase 1 study testing KAN-004 in people with Colitis and Diarrhea Caused by Antitumor Drugs, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Diarrhea Caused by Antitumor Drugs
- What is being tested?
- KAN-004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2026to 31 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
About this study
Official title: A Phase I Study of KAN-004 in Patients With 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.
- Conditions
- Colitis, Diarrhea Caused by Antitumor Drugs
- Being tested
- KAN-004
- Medical subject headings
- Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Participants with steroid-naïve irColitis | Experimental | Participants with non-steroid refractory irColitis Receives: Biological: KAN-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColitisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arielle Elkrief, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196410
- Sponsor's protocol ID
- MP-02-2026-12952 (AE-KAN-004)
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis
- ClinicalTrials.gov ID
- NCT07196410
- Acronym / sponsor ID
- MP-02-2026-12952 (AE-KAN-004)
- Conditions
- Colitis, Diarrhea Caused by Antitumor Drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with steroid-naïve irColitis | Experimental | Biological: KAN-004Participants with non-steroid refractory irColitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KAN-004Each 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 | Biological | Participants with steroid-naïve irColitis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arielle Elkrief, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KAN-004 in people with Colitis and Diarrhea Caused by Antitumor Drugs, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wiam Belkaid, PhD (514-836-3273, wiam.belkaid.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004 (time frame: 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.