KAN-004 for Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of a new treatment called KAN-004, a potential drug for individuals with immune-related colitis, where the immune system attacks the colon, causing inflammation. Participants must have previously received treatment for a solid tumor with a specific cancer drug and now have colitis untreated by steroids. The trial requires participants who can swallow pills and are willing to provide blood and stool samples. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that KAN-004 is likely to be safe for humans?
Research has shown that KAN-004 has been studied for its safety in treating immune-related colitis. Researchers collected safety information from the start of treatment up to one year after stopping it, carefully monitoring for any side effects or problems over an extended period. However, since the trial is in an early stage, the full safety profile in humans is still being understood. Early trials primarily focus on ensuring a treatment's safety, so KAN-004 is expected to be generally well-tolerated. Nonetheless, rare or long-term side effects might not yet be fully known.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for colitis, which often rely on steroids to reduce inflammation, KAN-004 is being explored for its potential to help those who haven't used steroids before. Researchers are excited about KAN-004 because it may offer a new way to manage colitis without the typical side effects of steroids, such as weight gain and weakened bones. This drug could provide a more targeted approach to treating inflammation, potentially improving comfort and quality of life for patients.
What evidence suggests that KAN-004 might be an effective treatment for colitis?
Research has shown that KAN-004, the investigational treatment in this trial, produced promising results in early studies for treating immune-related colitis (irColitis), a type of bowel inflammation. In lab tests, KAN-004 reduced colitis symptoms and improved the body's ability to fight tumors. Researchers hope KAN-004 could enable patients to continue cancer treatment longer by easing colitis symptoms. Overall, these early findings suggest KAN-004 might effectively manage irColitis, but further studies are needed to confirm these results in people.16789
Who Is on the Research Team?
Arielle Elkrief, MD
Principal Investigator
Centre Hospitalier de l'Universite de Montreal (CHUM)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with immune-related colitis from cancer treatment, who can take pills and agree to provide samples. They must have had a solid tumor treated with specific drugs recently but not be pregnant, breastfeeding, HIV-positive, or have certain other health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KAN-004 for immune-related colitis to evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KAN-004
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor