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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2 Study of Oncobax®-AK Administered in Combination With Immunotherapy To Patients With Advanced Solid Tumors

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

Intervention / Treatment
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* Other: Live Bacterial Product - Akkermansia muciniphila


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 cohort of patients with NSCLC recruited in parallel to 1 cohort recruiting RCC patients.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | iRECIST | 9 months | 

Secondary Outcome Measures

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