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A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU Ambroise Paré
Mons, Belgium
Centre Georges Francois Leclerc
Dijon, France
Institut Gustave Roussy
Paris, France
ICANS - Institut de cancérologie Strasbourg
Strasbourg, France
Start Date
October 1, 2022
Primary Completion Date
June 1, 2025
Completion Date
June 1, 2026
Last Updated
May 19, 2023
122
ESTIMATED participants
Live Bacterial Product - Akkermansia muciniphila
OTHER
Lead Sponsor
EverImmune
NCT06667908
NCT04165798
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06875310