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    Summary
    EudraCT Number:2022-001136-28
    Sponsor's Protocol Code Number:OSE-279-C101
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-19
    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 number2022-001136-28
    A.3Full title of the trial
    A multicenter, phase 1/2, dose-finding and dose expansion study of OSE-279,
    a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dose-finding and dose expansion study of OSE-279 in subjects with advanced solid tumors or lymphomas
    A.4.1Sponsor's protocol code numberOSE-279-C101
    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 SponsorOSE Immunotherapeutics
    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 supportOSE Immunotherapeutics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOSE Immunotherapeutics
    B.5.2Functional name of contact pointOSE Contact
    B.5.3 Address:
    B.5.3.1Street Address22 boulevard Benoni Goullin
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44200
    B.5.3.4CountryFrance
    B.5.6E-mailcontact@ose-immuno.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 Information not present in EudraCT
    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 nameOSE-279
    D.3.2Product code OSE-279
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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
    Advanced solid tumors and lymphomas
    E.1.1.1Medical condition in easily understood language
    Solid tumors and lymphomas
    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 LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Doses (RP2D)
    E.2.2Secondary objectives of the trial
    To assess the antitumor activity
    To evaluate the safety profile
    To evaluate the pharmacokinetic (PK) profile
    To evaluate immunogenicity (ADA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I-1. Male or female adult patients (≥ 18 years at the time of ICF signature).
    I-2. Signed and dated informed consent (ICF) prior to any trial-specific procedures. Patients should be able and willing to comply with study visits and procedures as per protocol.
    I-3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
    I-4. Tumor type:
    a. advanced solid tumors or lymphomas for which anti-PD-1/PD-L1 has shown efficacy (e.g., with high microsatellite instability or MSI-H) but is not available in the center/country (no marketing authorization, no reimbursement, no early access program, etc.), or;
    b. rare tumors with reported significant activity of anti-PD1 (e.g., TLS+ sarcomas, alveolar soft part sarcomas, etc.), or;
    c. PD-L1 positive tumors.
    I-5. Prior treatment with at least one line of systemic therapy and no standard of care available.
    I-6. Evaluable or measurable disease according to RECIST 1.1/RECIL (Ribrag 2017).
    I-7. Patient with adequate organ function:
    a. Bone marrow: neutrophils ≥ 1.5 x 109/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 109L.
    b. Renal function: serum creatinine ≤ 1.5 ULN or CKD-EPI creatinine clearance ≥ 30 mL/min.
    c. Liver function: AST and ALT ≤ 3 ULN, bilirubin ≤ 1.5 ULN. In case of liver metastasis: AST and ALT ≤ 5 ULN. For patients with Gilbert’s syndrome total bilirubin ≤ 3 ULN or direct bilirubin ≤ 1.5 ULN.
    I-8. Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.
    E.4Principal exclusion criteria
    1.Patient eligible to surgical resection or another approved therapeutic regimen known to provide clinical benefit
    2.Patient previously treated with an approved or investigational anti-PD-1/PD-L1
    3.Patient with active autoimmune disease or a documented history of autoimmune disease requiring systemic treatment (i.e., corticosteroids or immunosuppressive drugs); except autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone, controlled hypophysitis, controlled Type 1 diabetes mellitus on a stable insulin regimen, vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition not requiring systemic therapy
    4.Patient participating in another clinical trial with a medicinal product
    5.Patients who have not recovered from adverse events (i.e., > Grade 1 according to CTCAE v5.0) due to prior treatment with anti-cancer agents with exception of Grade 2 neuropathy or any grade alopecia. Lab values must be within the limits presented in criterion I-7
    6.Patients with known additional malignancy progressing or requiring active treatment Basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer are not exclusion criteria
    7.Patients with known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to C1D1 and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids (at doses higher than 10 mg/d of methylprednisolone or equivalent) for at least 4 weeks prior C1D1
    8.Patients with active or history of non-infectious pneumonitis requiring steroids, or interstitial lung disease
    9.Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient’s participation for the full duration of the study
    10.Patients with a history of uncontrolled or symptomatic, clinically significant cardiovascular disease: stroke, myocardial infarction, angina pectoris, arrhythmias, congestive heart failure (NYHA Class >2), or myocarditis within 6 months prior to first study drug administration
    11.Patient with organ(s) transplanted including hematopoietic stem cell allograft
    12.Patients receiving or to be treated during the treatment period with one of the following forbidden treatments
    a.Any anti-cancer systemic chemotherapy, targeted therapy or biological therapy including any immunotherapy not mentioned in this protocol. Washout prior to screening: chemotherapy: 3 weeks (6 weeks for nitrosourea), TKi or other small molecules: 2 weeks or 5 half-lives whichever is shortest, mAbs: 4 weeks
    b.Radiation therapy (washout prior to screening: 7 days prior to Cycle 1)
    c.Live vaccines. Examples but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, tuberculosis (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
    d.Recent major surgery (<3 months)
    e.Systemic corticosteroids for any purpose other than to modulate symptoms from an event of clinical interest of suspected immunologic etiology. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. Immunosuppressive agents such as steroids should be tapered off before initiation of study treatment (except low-dose up to a total dose equivalent to prednisolone 10 mg/day)
    13.Patients with hypersensitivity to OSE-279 or any of its excipients.
    14.Patients with active tuberculosis
    15.Patients with: Active hepatitis B, Active hepatitis C, Active HIV infection: HIV+ patients on highly active antiretroviral therapy are eligible if PCR for HIV is negative at screening, Presence of signs/symptoms suggestive of active infection (including COVID-19 infection)
    16.Patients with known psychiatric or substance abuse disorders that would interfere their ability to comply with protocol requirements
    17.WOCBP and men participating in the study (and their partners) must agree to follow the precautions to avoid gestational problems by using highly efficient contraception throughout the study and until 8 months after the last administration of investigational treatment based on CTFG guidance. In addition, during this study period men should use condoms and avoid semen donation
    18.Women who are pregnant or breast-feeding or women/men expecting to conceive children within the projected duration of the trial, starting with the screening visit through 8 months after the last dose of trial treatment
    19. Vulnerable persons, if applicable as per local regulations
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of dose limiting toxicity (DLT) for MTD determination
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT observation period is defined as the first 21 days after receiving the 1st injection of OSE-279
    E.5.2Secondary end point(s)
    Efficacy:
    - Objective Response Rate (ORR: CR and PR)
    - Disease Control Rate (DCR: CR, PR and SD)
    - Time to response
    - Duration of response (DR)
    - Progression Free Survival (PFS)
    • DCR at 12 weeks
    • Overall Survival (OS)

    Pharmacokinetics and Pharmacodynamics:
    • Pharmacokinetic parameters
    • Detection of anti-OSE-279 antibodies

    Safety:
    Nature, incidence and severity of TEAE (including DLT and AE of special Interest (AESI)), of SAE, SUSARs graded according to CTC-AE grading.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments throughout the entire study duration.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Yes
    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
    The End of Trial is defined as last patient last visit i.e. either the date of the last visit of the last patient to complete the study or the date at which the last data point from the last patient, which is required for endpoints analysis, is received whichever is the latest.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Patients who experience benefits may be eligible for continued treatment after discussion with sponsor.
    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 Decision2022-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-08
    P. End of Trial
    P.End of Trial StatusOngoing
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