KAN-004 for Colitis

AS
WB
Overseen ByWiam Belkaid, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AE

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

Able to ingest capsules
Consent to provide blood and stool samples
Accessible for treatment and follow-up
See 4 more

Exclusion Criteria

Pregnancy or breastfeeding
I am HIV-positive.
I have been diagnosed with malabsorption before.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KAN-004 for immune-related colitis to evaluate safety and tolerability

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KAN-004
Trial Overview The study tests KAN-004's safety and how well patients tolerate it when they have diarrhea or colitis caused by the body's immune response after cancer therapy.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants with steroid-naïve irColitisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Citations

1036 KAN-004, a metabolically complete live ...Conclusions KAN-004 demonstrates preclinical efficacy in resolving irColitis and enhancing antitumor immunity in various models. Novel method ...
(PDF) 1036 KAN-004, a metabolically complete live ...Safety data was collected from dosing until 1-year following cessation. Exploratory analysis included evaluation of pre- and post-treatment ...
Recapping Kanvas Bio's 2024 Science Day: A Q&A…We expect that successful results for KAN-004 can resolve colitis symptoms, with the potential to allow patients to stay on ICI longer and improve ICI therapy ...
AbstractsIn an E0771 ICI resistant tumor model, combination anti-PD-1 and KAN-004 treatment showed a trend for decrease in tumor size compared to isotype control. (p = ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40239400/
The association between metformin use, immune mediated ...We collected data on demographic and colitis clinical information including treatments, and outcomes. Results: A total of 953 patients were ...
KAN-004 for Colitis · Info for ParticipantsThe goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis. Who Is on the Research Team? AE.
An updated review on immune checkpoint inhibitor-induced ...Immune checkpoint inhibitor-induced colitis (irColitis) is a common and severe adverse reaction to immune checkpoint inhibitors (ICIs), ...
Iatrogenic effect of immune checkpoint inhibitors and ...Anti-PD-L1/PD1 and anti-CTLA-4 induced colitis similar to microscopic colitis and inflammatory bowel disease (IBD)-like, and rarely perforation.
ZEPOSIA® (ozanimod) UC Safety Profile | For HCPsLearn more about ZEPOSIA® safety profile data and adverse reactions in ulcerative colitis clinical trials. See Safety Info and Full Prescribing Information.
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