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    Summary
    EudraCT Number:2022-000163-53
    Sponsor's Protocol Code Number:EV-2101
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-000163-53
    A.3Full title of the trial
    A PHASE 1/2 STUDY OF ONCOBAX®-AK ADMINISTERED IN COMBINATION WITH IMMUNOTHERAPY TO PATIENTS WITH ADVANCED SOLID TUMORS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PHASE 1/2 STUDY OF ONCOBAX®-AK ADMINISTERED IN COMBINATION WITH IMMUNOTHERAPY TO PATIENTS WITH ADVANCED SOLID TUMORS
    A.3.2Name or abbreviated title of the trial where available
    6EVE1
    A.4.1Sponsor's protocol code numberEV-2101
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEverImmune SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEverImmune SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEverImmune SAS
    B.5.2Functional name of contact pointAlain Thibault
    B.5.3 Address:
    B.5.3.1Street Address39 rue Camille Desmoulins
    B.5.3.2Town/ cityVillejuif
    B.5.3.3Post code94800
    B.5.3.4CountryFrance
    B.5.6E-mailalain.thibault@everimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOncobax®-AK
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFreeze-dried culture of Akkermansia EIA, PB0146
    D.3.9.2Current sponsor codeAkk p2261
    D.3.9.3Other descriptive nameAkkermansia p2261, Akkermansia EIA, PB0146
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1000000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Non-Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC)
    E.1.1.1Medical condition in easily understood language
    Advanced solid tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10038395
    E.1.2Term Renal carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1: Characterize the safety profile and tolerability of repeated doses of Oncobax®-AK administered in combination with PD-L1-based chemo-immunotherapy in metastatic NSCLC or RCC patients deficient in Akkermansia.

    Phase 2: Characterize the efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients and deficient in Akkermansia.
    E.2.2Secondary objectives of the trial
    Phase 2: Characterize the:
    - efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients
    - safety profile and tolerability of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed Stage IV NSCLC or clear cell RCC.
    2. Patient eligible for SOC PD-L1 based immunotherapy or chemo-immunotherapy (for NSCLC) and ipilimumab + nivolumab (for RCC).
    3. NSCLC cohort-specific criterion: best tumor response (by iRECIST) as stable disease (SD) between 12 and 18 weeks after initiation of first line PD-L1-based –immunotherapy or chemo-immunotherapy.
    4. RCC cohort-specific criterion: intermediate- or poor-risk35 newly diagnosed RCC patients (clear cell histology).
    5. Negative stool polymerase chain reaction (PCR) test for Akkermansia (A. muciniphila and A. massiliensis) as defined in paragraph 11.2.7.2. of the protocol.
    6. NSCLC Cohort-specific criterion: PD-L1 expression data ≥1%.
    7. At least one measurable (target) lesion per iRECIST.
    8. Eastern Cooperative Oncology Group (ECOG) performance status = 0-1.
    9. Age >18 years.
    10. Hemoglobin ≥90 g/L.
    11. Neutrophil count ≥1.0 x 109/L.
    12. Platelet count ≥75 x 109/L.
    13. Lymphocyte count > 0.5 x 10e9/L.
    14. Albumin >30 g/L.
    15. A wash-out period of 5 half-lives or more since the last dose administered of any investigational medicinal products or chemotherapy received previously.
    16. For patients of child-bearing potential, commitment to use a birth control method with a failure rate of less than 1% per year, during the entire treatment period AND for at least 4 months after the last dose of ICI (for NSCLC patients) OR at least 5 months after the last dose of nivolumab (for RCC patients).
    17. Signed informed consent form.
    E.4Principal exclusion criteria
    1. Symptomatic brain metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period.
    2. Alanine aminotransferase (ALT) >5 times the upper limit of normal range (ULN).
    3. Calculated creatinine clearance <40 mL/min.
    4. Auto-immune diseases requiring systemic therapy.
    5. Immunosuppressive therapy (>10 mg prednisone/day equivalent) within 4 weeks of signed informed consent.
    6. Known allergy to Oncobax®-AK excipients.
    7. Radiotherapy (>30 Gy) to the lung(s) within 6 months of signed informed consent.
    8. Active infection. A 4-week delay must have elapsed between the resolution of any systemic infection and the initiation of Oncobax®-AK administration.
    9.Vaccination with a live attenuated virus, other than influenza, within 6 months of signed informed consent.
    10. Pregnancy or breast-feeding.
    11. Active inflammatory bowel disease and/or any medical condition that alters the integrity of the intestinal barrier.
    12. Other co-morbidities that, in the opinion of the Investigator, may place the patient at a higher risk of treatment-related AEs.
    13. Inability to comply with protocol-specific assessments.
    14. Patient is subject to any of the following procedures: ward of court, trusteeship, supervision order, applied mandate of future protection.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1:
    - AEs, TEAEs, related TEAEs, SAEs, DLTs per NCI-CTCAE version 5.0
    - Dose reductions and interruptions

    Phase 2:
    - ORR per iRECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    Phase 2:
    - PFS9, OS12, DOR
    - AEs, TEAEs, related, TEAEs, SAEs, DLTs per NCI-CTCAE version 5.0
    - Dose reductions and interruptions
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 128
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 128
    F.4.2.2In the whole clinical trial 128
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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