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

EverImmune

Status and phase: Enrolling; Phase 2

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

Treatments: Other: Live Bacterial Product - Akkermansia muciniphila

Study type: Interventional

Funder types: Industry

Identifiers

NCT05865730

EV-2101

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Phase 2 - NSCLC

Experimental group

Description:

Oncobax-AK (1 capsule) will be administered daily until PD\< excessive toxicity or withdrawal of consent

Treatment:

Other: Live Bacterial Product - Akkermansia muciniphila

Phase 2 -RCC

Experimental group

Description:

Oncobax-AK (1 capsule) will be administered daily until PD\< excessive toxicity or withdrawal of consent

Treatment:

Other: Live Bacterial Product - Akkermansia muciniphila