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
Qualifiers
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
Treatments tested in this trial
- KAN-004
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov