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
Study summary
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004 — 6 weeks of treatment Proportion of participants with non-steroid refractory irColitis experiencing adverse events as measured by CTCAE v5.
Trial sites (1)
Facility
City
Region
Status
Centre Hospitalier de l'Universite de Montreal
Montreal
Quebec
Recruiting
More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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