Spots Global Cancer Trial Database for A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Official Title: A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
Study ID: NCT05865730
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Ambroise Paré, Mons, , Belgium
Centre Georges Francois Leclerc, Dijon, , France
Institut Gustave Roussy, Paris, , France
ICANS - Institut de cancérologie Strasbourg, Strasbourg, , France
Contact Details
Name: Fabrice Barlesi, MD, PhD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: PRINCIPAL_INVESTIGATOR
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