KAN-004 for Immune-Related Diarrhea or Colitis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior/concurrent malignancy that could interfere with safety/efficacy assessment.
Colostomy.
Prior diagnosis of malabsorption.
Untreated chronic hepatitis B or C.
Trial design
Design model
Single group
Treatments tested in this trial
KAN-004
Biological/VaccineEach 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
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Participants with steroid-naïve irColitisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 weeks of treatmentSponsors and contacts
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Source ClinicalTrials.gov