NCT05865730

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: EverImmune · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	Live Bacterial Product - Akkermansia muciniphila	Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.

Timeline

• Start date: 2022-10-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-05-19
• Last updated: 2023-05-19

Locations

4 sites across 2 countries: Belgium, France