Back to resultsA Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Primary Purpose
Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Live Bacterial Product - Akkermansia muciniphila
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell
Eligibility Criteria
Inclusion Criteria: Age > 18 years Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease NSCLC-specific criterion: PD-L1 expression > 50% ECOG Performance Status = 0-1 Negative stool PCR test for Akkermansia At least one measurable lesion per iRECIST Hemoglobin ≥ 100 g/L Albumin > 35 g/L Signed informed consent Exclusion Criteria: Symptomatic brain metastases AST or ALT > 5 x ULN Calculated creatinine clearance < 45 ml/min Auto-immune diseases requiring systemic therapy Immunosuppressive therapy (> 10 mg prednisone/day equivalent) Radiotherapy (> 30 Gy) to the lung(s) within 6 months of signed informed consent Active infection Co-morbidities that may increase the risk of treatment-related adverse events Pregnancy Inability to comply with protocol-specific assessments
Sites / Locations
- CHU Ambroise ParéRecruiting
- Centre Georges Francois LeclercRecruiting
- Institut Gustave RoussyRecruiting
- ICANS - Institut de cancérologie StrasbourgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase 2 - NSCLC
Phase 2 -RCC
Arm Description
Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent
Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent
Outcomes
Primary Outcome Measures
Objective Response Rate
iRECIST
Secondary Outcome Measures
Progression-free survival
iRECIST
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05865730
Brief Title
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Official Title
A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EverImmune
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase 2 - NSCLC
Arm Type
Experimental
Arm Description
Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent
Arm Title
Phase 2 -RCC
Arm Type
Experimental
Arm Description
Oncobax-AK (1 capsule) will be administered daily until PD< excessive toxicity or withdrawal of consent
Intervention Type
Other
Intervention Name(s)
Live Bacterial Product - Akkermansia muciniphila
Intervention Description
Oral administration of Oncobax-AK to patients deficient in Akkermansia by stool metagenomic analysis.
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
iRECIST
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
iRECIST
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Histologically confirmed Stage IV non-squamous NSCLC or clear cell RCC
NSCLC-specific criterion: Best tumor response (by iRECIST) as Stable Disease
NSCLC-specific criterion: PD-L1 expression > 50%
ECOG Performance Status = 0-1
Negative stool PCR test for Akkermansia
At least one measurable lesion per iRECIST
Hemoglobin ≥ 100 g/L
Albumin > 35 g/L
Signed informed consent
Exclusion Criteria:
Symptomatic brain metastases
AST or ALT > 5 x ULN
Calculated creatinine clearance < 45 ml/min
Auto-immune diseases requiring systemic therapy
Immunosuppressive therapy (> 10 mg prednisone/day equivalent)
Radiotherapy (> 30 Gy) to the lung(s) within 6 months of signed informed consent
Active infection
Co-morbidities that may increase the risk of treatment-related adverse events
Pregnancy
Inability to comply with protocol-specific assessments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Thibault, MD
Phone
+32472196345
Email
alain.thibault@everimmune.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Barlesi, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Ambroise Paré
City
Mons
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Holbrechts, MD
Facility Name
Centre Georges Francois Leclerc
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Ghiringhelli, MD, PhD
Facility Name
Institut Gustave Roussy
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Albiges, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lisa Derosa, Md, PhD
Facility Name
ICANS - Institut de cancérologie Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Barthelemy, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35115705
Citation
Derosa L, Routy B, Thomas AM, Iebba V, Zalcman G, Friard S, Mazieres J, Audigier-Valette C, Moro-Sibilot D, Goldwasser F, Silva CAC, Terrisse S, Bonvalet M, Scherpereel A, Pegliasco H, Richard C, Ghiringhelli F, Elkrief A, Desilets A, Blanc-Durand F, Cumbo F, Blanco A, Boidot R, Chevrier S, Daillere R, Kroemer G, Alla L, Pons N, Le Chatelier E, Galleron N, Roume H, Dubuisson A, Bouchard N, Messaoudene M, Drubay D, Deutsch E, Barlesi F, Planchard D, Segata N, Martinez S, Zitvogel L, Soria JC, Besse B. Intestinal Akkermansia muciniphila predicts clinical response to PD-1 blockade in patients with advanced non-small-cell lung cancer. Nat Med. 2022 Feb;28(2):315-324. doi: 10.1038/s41591-021-01655-5. Epub 2022 Feb 3.
Results Reference
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PubMed Identifier
32376136
Citation
Derosa L, Routy B, Fidelle M, Iebba V, Alla L, Pasolli E, Segata N, Desnoyer A, Pietrantonio F, Ferrere G, Fahrner JE, Le Chatellier E, Pons N, Galleron N, Roume H, Duong CPM, Mondragon L, Iribarren K, Bonvalet M, Terrisse S, Rauber C, Goubet AG, Daillere R, Lemaitre F, Reni A, Casu B, Alou MT, Alves Costa Silva C, Raoult D, Fizazi K, Escudier B, Kroemer G, Albiges L, Zitvogel L. Gut Bacteria Composition Drives Primary Resistance to Cancer Immunotherapy in Renal Cell Carcinoma Patients. Eur Urol. 2020 Aug;78(2):195-206. doi: 10.1016/j.eururo.2020.04.044. Epub 2020 May 4.
Results Reference
background
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A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
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