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KAN-001 + Pembrolizumab for Non-Small Cell Lung Cancer

Not yet recruiting at 1 trial location
CD
Vo
Overseen ByVP of Clinical Research
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Kanvas Biosciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this Phase 1 clinical trial is to learn whether KAN-001, an investigational live biotherapeutic product, can be safely given with pembrolizumab, with or without chemotherapy, to adults with PD-L1-positive, inoperable or metastatic non-small cell lung cancer. The main questions it aims to answer are:

* What side effects occur when KAN-001 is given with pembrolizumab, with or without chemotherapy?

* Can the microbial strains contained in KAN-001 be detected in participants' stool after treatment?

Participants will:

* Complete a bowel preparation before receiving the first dose of KAN-001.

* Take a loading dose of KAN-001, followed by maintenance doses every 3 weeks.

* Receive pembrolizumab every 3 weeks. Some participants will also receive chemotherapy.

* Provide blood, stool, and stool-wipe samples and complete a gastrointestinal symptom diary.

* Undergo imaging scans and other study assessments to monitor their cancer, health, and safety.

Are You a Good Fit for This Trial?

This trial is for adults with non-small cell lung cancer that cannot be removed by surgery or has spread, and whose tumors test positive for PD-L1. Participants must be able to undergo bowel preparation and provide samples during the study.

Inclusion Criteria

I have been diagnosed with non-small cell lung cancer by a lab test.
I am fully active or have only minor physical limitations.
Participant is willing and able to provide written informed consent for the trial
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Exclusion Criteria

Unwillingness or inability to swallow size 0 capsules
Screening blood test results outside required ranges or positive tests for HIV, hepatitis B, or hepatitis C
Any past or current medical, psychiatric, or substance-use condition, therapy, or laboratory abnormality that could affect study results or participation
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What Are the Treatments Tested in This Trial?

Interventions

  • KAN-001
  • Pembrolizumab

Trial Overview

The study tests KAN-001 (a new live biotherapeutic) given with pembrolizumab, with or without chemotherapy. It aims to find out if this combination is safe and how it affects the body in people with advanced lung cancer.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Cohort 3: ICI refractory (pembrolizumab)Experimental Treatment2 Interventions
Group II: Cohort 2: ICI naïve (pembrolizumab and chemotherapy)Experimental Treatment1 Intervention
Group III: Cohort 1: ICI naïve (pembrolizumab)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kanvas Biosciences

Lead Sponsor

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