KAN-004 treatment for immune-related diarrhea and colitis
Official title: A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis
Run by Centre hospitalier de l'Université de Montréal (CHUM) · NCT07196410 · Data updated 2026-11-12
This trial is testing whether KAN-004 is safe and tolerable for adults who develop moderate-to-severe diarrhea or colitis after treatment with immune checkpoint inhibitors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 21 (estimated) |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07196410 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a solid tumor who recently received immune checkpoint inhibitors and now have clinically diagnosed immune-related diarrhea or colitis above CTCAE grade 2, can swallow capsules, provide samples, and travel to Montreal for visits are ideal candidates.
✕Probably not a fit
Patients with a colostomy, malabsorption, active untreated hepatitis B or C, HIV, solid-organ transplant, pregnancy or breastfeeding, or other concurrent malignancies are excluded and unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 1 interventional trial administering oral KAN-004 capsules to adults with immune-related colitis or diarrhea following immune checkpoint inhibitor therapy to test safety and tolerability. Eligible participants have a solid tumor, received at least one cycle of checkpoint inhibitor within the prior 180 days, and have clinically diagnosed immune-related colitis of greater than CTCAE grade 2. Participants will provide blood and stool samples and attend treatment and follow-up visits at the study site in Montreal. Key exclusions include prior solid-organ transplant, untreated hepatitis B or C, HIV infection, colostomy, malabsorption, pregnancy, breastfeeding, or other malignancies that could interfere with assessments.
Why it matters
Potential benefit: If successful, KAN-004 could provide a new oral treatment option to control immune-related diarrhea and colitis and help patients continue cancer therapy with fewer interruptions.
How similar studies have gone: There is limited public data on KAN-004 specifically, although established treatments like corticosteroids, infliximab, and vedolizumab have shown benefit for immune-related colitis, making this a novel agent in a known treatment area.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Arielle Elkrief, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Wiam Belkaid, PhD
- Email: wiam.belkaid.chum@ssss.gouv.qc.ca
- Phone: 514-836-3273
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.