RecruitingPhase 2NCT05865730

A Study of Oncobax®-AK in Patients With Advanced Solid Tumors

A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors


Sponsor

EverImmune

Enrollment

122 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract. Analysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore / improve the efficacy of immunotherapy in patients with NSCLC or RCC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests Oncobax-AK, a probiotic-based treatment (using Akkermansia bacteria), in people with advanced non-small cell lung cancer or kidney cancer (clear cell type) to see if adding it improves how the immune system fights cancer. **You may be eligible if...** - You are over 18 years old with confirmed stage IV non-squamous lung cancer or clear cell kidney cancer - For lung cancer: your disease is stable (not progressing) and your tumor expresses high levels of PD-L1 (greater than 50%) - You do not have detectable Akkermansia bacteria in your stool - You are in good general health (ECOG 0–1) with at least one measurable tumor **You may NOT be eligible if...** - You have symptomatic brain metastases - You have active autoimmune disease requiring systemic treatment - You are currently on high-dose immune-suppressing steroids - You have had significant radiation to the lungs in the past 6 months - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLive Bacterial Product - Akkermansia muciniphila

Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.


Locations(4)

CHU Ambroise Paré

Mons, Belgium

Centre Georges Francois Leclerc

Dijon, France

Institut Gustave Roussy

Paris, France

ICANS - Institut de cancérologie Strasbourg

Strasbourg, France

View Full Details on ClinicalTrials.gov

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NCT05865730


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