Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05865730
PHASE2

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

Sponsor: EverImmune

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2022-10-01

Completion Date

2026-06

Last Updated

2023-05-19

Healthy Volunteers

No

Interventions

OTHER

Live 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