Colitis, Diarrhea Caused by Antitumor Drugs
Conditions
Brief summary
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Interventions
BIOLOGICALKAN-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
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Contacts
CONTACTWiam Belkaid, PhD
PRINCIPAL_INVESTIGATORArielle Elkrief, MD
Centre Hospitalier de l'Universite de Montreal (CHUM)
Outcome results
None listed