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RECRUITINGPhase 2NCT05865730

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

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 Akkerm...

Lead sponsor: EverImmune•4 locations•View source on ClinicalTrials.gov

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Contacts

Alain Thibault, MD

CONTACT

+32472196345 alain.thibault@everimmune.com

Sponsors

Lead Sponsor

EverImmune

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 19, 2023Terms

Trial snapshot

StatusRECRUITING

PhasePHASE2

Enrollment122

Start dateOct 2022

Last updatedMay 19, 2023

Condition

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

Locations shown

CHU Ambroise Paré

Mons

Centre Georges Francois Leclerc

Dijon

Institut Gustave Roussy

Paris

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2023Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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