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

May 9, 2023 updated by: EverImmune

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Mons, Belgium
        • Recruiting
        • CHU Ambroise Pare
        • Contact:
          • Stephane Holbrechts, MD
  • France
      • Dijon, France
        • Recruiting
        • Centre Georges Francois Leclerc
        • Contact:
          • François GHIRINGHELLI, MD, PhD
      • Paris, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Laurence Albiges, MD, PhD
        • Sub-Investigator:
          • Lisa Derosa, Md, PhD
      • Strasbourg, France
        • Recruiting
        • ICANS - Institut de Cancérologie Strasbourg
        • Contact:
          • Philippe Barthelemy, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 18 years
  2. Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
  3. NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
  4. NSCLC-specific criterion: PD-L1 expression > 50%
  5. ECOG Performance Status = 0-1
  6. Negative stool PCR test for Akkermansia
  7. At least one measurable lesion per iRECIST
  8. Hemoglobin ≥ 100 g/L
  9. Albumin > 35 g/L
  10. Signed informed consent

Exclusion Criteria:

  1. Symptomatic brain metastases
  2. AST or ALT > 5 x ULN
  3. Calculated creatinine clearance < 45 ml/min
  4. Auto-immune diseases requiring systemic therapy
  5. Immunosuppressive therapy (> 10 mg prednisone/day equivalent)
  6. Radiotherapy (> 30 Gy) to the lung(s) within 6 months of signed informed consent
  7. Active infection
  8. Co-morbidities that may increase the risk of treatment-related adverse events
  9. Pregnancy
  10. Inability to comply with protocol-specific assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2 - NSCLC
Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent
Other: Live Bacterial Product - Akkermansia muciniphila
Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.
Experimental: Phase 2 -RCC
Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent
Other: Live Bacterial Product - Akkermansia muciniphila
Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 9 months
iRECIST
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 9 months
iRECIST
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EverImmune

Investigators

  • Principal Investigator: Fabrice Barlesi, MD, PhD, Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EV-2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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