KAN-004 for Immune-Related Diarrhea or Colitis

Phase 1Not Yet RecruitingNCT07196410

Centre hospitalier de l'Université de Montréal (CHUM)21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colitis Diarrhea Caused by Antitumor Drugs

Interventions

KAN-004BIOLOGICAL

Each 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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 treatment

Central Contacts

Anna S Perez

CONTACT

514-890-8000 anna.perez.chum@ssss.gouv.qc.ca

Wiam Belkaid, PhD

CONTACT

wiam.belkaid.chum@ssss.gouv.qc.ca

Data from ClinicalTrials.gov

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