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

NCT05865730 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-05-19

No results posted yet for this study

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.

Conditions

  • Carcinoma, Renal Cell
  • Carcinoma, Non-Small-Cell Lung

Interventions

OTHER

Live Bacterial Product - Akkermansia muciniphila

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

Sponsors & Collaborators

  • EverImmune

    lead INDUSTRY

Principal Investigators

  • Fabrice Barlesi, MD, PhD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05865730 on ClinicalTrials.gov