Overview
The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.
Eligibility
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.
