OncoMatch/Clinical Trials/NCT05865730
A Study of Oncobax®-AK in Patients With Advanced Solid Tumors
Is NCT05865730 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for carcinoma, renal cell.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression > 50% (> 50%)
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: ≤ 30 Gy to the lung(s) within 6 months allowed
Radiotherapy (> 30 Gy) to the lung(s) within 6 months of signed informed consent
Lab requirements
Blood counts
Hemoglobin ≥ 100 g/L; Albumin > 35 g/L
Kidney function
calculated creatinine clearance ≥ 45 ml/min
Liver function
AST or ALT ≤ 5 x ULN
AST or ALT > 5 x ULN [excluded]; Calculated creatinine clearance < 45 ml/min [excluded]; Hemoglobin ≥ 100 g/L; Albumin > 35 g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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