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

Sponsor
EverImmune (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05865730
Collaborator
(none)
122
Enrollment
4
Locations
2
Arms
44
Anticipated Duration (Months)
30.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Live Bacterial Product - Akkermansia muciniphila
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
122 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate [9 months]

    iRECIST

Secondary Outcome Measures

  1. Progression-free survival [9 months]

    iRECIST

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Ambroise Paré Mons Belgium
2 Centre Georges Francois Leclerc Dijon France
3 Institut Gustave Roussy Paris France
4 ICANS - Institut de cancérologie Strasbourg Strasbourg France

Sponsors and Collaborators

  • EverImmune

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
EverImmune
ClinicalTrials.gov Identifier:
NCT05865730
Other Study ID Numbers:
  • EV-2101
First Posted:
May 19, 2023
Last Update Posted:
May 19, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell

Study Results

No Results Posted as of May 19, 2023