Recruiting NCT07196410
KAN-004 for Immune-Related Diarrhea or Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KAN-004.
- Who it may be relevant to
- Registry conditions: Colitis, Diarrhea Caused by Antitumor Drugs. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis
Overview
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Interventions
- Biological 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
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004 [Time frame: 6 weeks of treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Centre Hospitalier de l'Universite de Montreal — Montreal
Identifiers
NCT: NCT07196410 · MP-02-2026-12952 (AE-KAN-004)