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

Phase 2

Recruiting

• Conditions: Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung
• Interventions: Other: Live Bacterial Product - Akkermansia muciniphila

• Registration Number: NCT05865730
• Lead Sponsor: EverImmune

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-03-20
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2 -RCC	Live Bacterial Product - Akkermansia muciniphila	Oncobax-AK (1 capsule) will be administered daily until PD\< excessive toxicity or withdrawal of consent
Phase 2 - NSCLC	Live Bacterial Product - Akkermansia muciniphila	Oncobax-AK (1 capsule) will be administered daily until PD\< excessive toxicity or withdrawal of consent

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	9 months	iRECIST

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	9 months	iRECIST

Trial Locations

Locations (4)

CHU Ambroise Paré; 🇧🇪 Mons, Belgium

Centre Georges Francois Leclerc; 🇫🇷 Dijon, France

Institut Gustave Roussy; 🇫🇷 Paris, France

ICANS - Institut de cancérologie Strasbourg; 🇫🇷 Strasbourg, France