KAN-004 for Immune-Related Diarrhea or Colitis (NCT07196410) | Clinical Trial Compass
RecruitingPhase 1
KAN-004 for Immune-Related Diarrhea or Colitis
Canada21 participantsStarted 2026-03-01
Plain-language summary
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events; Safety and tolerability of KAN-004