KAN-004 for Immune-Related Diarrhea or Colitis

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Not yet enrolling; Phase 1

Conditions: Colitis; Diarrhea Caused by Antitumor Drugs

Treatments: Biological: KAN-004

Study type: Interventional

Funder types: Other

Identifiers

NCT07196410

MP-02-2026-12952 (AE-KAN-004)

Details and patient eligibility

About

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

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Participants with steroid-naïve irColitis

Experimental group

Description:

Participants with non-steroid refractory irColitis

Treatment:

Biological: KAN-004