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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:Trial now transitioned
    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.IMP: 2
    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 nameOSE2101
    D.3.2Product code OSE2101
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    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 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous 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 24.0
    E.1.2Level LLT
    E.1.2Classification code 10085300
    E.1.2Term Squamous non-small cell lung cancer
    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
    Part A: To determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Doses (RP2D).
    Part B: To evaluate the safety and tolerability of the combination OSE-279/OSE2101.
    Part C: To assess the antitumor activity of OSE-279 in combination with OSE2101 versus 0SE-279 in terms of overall response rate (ORR) as assessed locally, in patients with 1st line metastatic (stage IV) NSCLC.
    E.2.2Secondary objectives of the trial
    Part A: To assess the antitumor activity; To evaluate the safety profile; To evaluate the pharmacokinetic (PK) profile; To evaluate immunogenicity (ADA).
    Part B: To preliminary determine the antitumor activity of the combination (ORR, DCR, DOR, TTR, DCR at 12 weeks and 24 weeks, PFS, OS and OS at 12 months).
    Part C: To further assess the efficacy of the combination of OSE-279/OSE2101 versus OSE-279 with respect to DCR,TTR, DOR, PFS, DCR at 12 weeks and 24 weeks, OS and OS rate at 12 months; To further evaluate the safety profile of both treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A, B and C:
    1. Male or female adult patients (≥ 18 years at the time of ICF signature).
    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.
    3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
    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.
    5. Prior treatment with at least one line of systemic therapy and no standard of care available.
    6. Evaluable or measurable disease according to RECIST 1.1/RECIL (Ribrag 2017).
    7. Patient with adequate organ function:
    a. Bone marrow: neutrophils ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9L.
    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.
    8. Patients must be affiliated to a social security system or an equivalent system, if applicable as per local regulations.

    Part B and C:
    In addition to the inclusion criteria of PART A:
    9. Patients expressing HLA-A2 phenotype on blood sample performed by an experienced laboratory using a validated test.(PCR or NGS); Additional patients HLA-A2 negative will be included in Part C.
    10. Tumor type:
    a. Histologically or cytologically documented Stage IV squamous or nonsquamous NSCLC not eligible for definite surgery or radiation, which does not have EGFR sensitizing (activating) mutation or ALK and ROS1 gene alterations eligible for targeted therapy or other mutations for which an approved therapy exists in 1st line metastatic setting (i.e.; KRAS G12C, RET, MET SKIP14, BRAFV600E mutations).
    b. Documented PD-L1 expression by TPS ≥ 50% by local testing.
    11. Patients must not have received prior systemic therapy including immunotherapy in the first-line metastatic setting; Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
    12. Patients with at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    E.4Principal exclusion criteria
    Part A, B and C:
    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 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, have no evidence of new or enlarging brain metastases, and are not using steroids 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 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.
    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.
    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.

    Part B and C:
    In addition to the non-inclusion criteria of PART A:
    20. Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas).
    21. Patients with hypersensitivity to OSE-279 or OSE-2101 or any of one of their excipients.
    22. Patients previously treated with anti-PD-L2, anti-CD137, or anti-Cytotoxic T-Lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    E.5 End points
    E.5.1Primary end point(s)
    Part A: Occurrence of dose limiting toxicity (DLT).
    Part B: Occurrence of dose limiting toxicity (DLT) where DLT observation period is defined as the first 6 weeks after receiving the first injections of OSE-279 and of OSE2101.
    Part C: ORR: Complete Response (CR) and Partial Response (PR) rate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A: DLT observation period is defined as the first 21 days after receiving the 1st injection of OSE-279.
    Part B: DLT observation period is defined as the first 6 weeks after receiving the first injections of OSE-279 and of OSE2101.
    E.5.2Secondary end point(s)
    Part A:
    • 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 (CR+PR+SD); 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.

    Part B:
    • Efficacy: ORR: Complete Response (CR) and Partial Response (PR) rate; DCR: CR, PR and Stable Disease (SD) rate; Time to response (TTR); Duration of Objective Response (DOR); Progression Free Survival (PFS); DCR (CR+PR+SD) at 12 weeks and 24 weeks; Overall Survival (OS); OS rate at 12 months.
    • Safety: Nature, incidence and severity of TEAE (including DLT and AE of special Interest (AESI)), of SAE, SUSARs graded according to CTCAE grading v5.0.

    Part C:
    • Efficacy: DCR: CR, PR and Stable Disease (SD) rate; Time to response (TTR); Duration of Objective Response (DOR); Progression Free Survival (PFS); DCR (CR+PR+SD) at 12 weeks and 24 weeks; Overall Survival (OS); OS rate at 12 months.
    • Safety: Nature, incidence and severity of TEAE (including DLT like events and AESI), of SAE, SUSARs graded according to CTCAE grading version 5.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A: Assessments throughout the entire Part A duration.
    Part B: Assessments throughout the entire Part B duration.
    Part C: Assessments throughout the entire Part C 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 Yes
    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 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 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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 47
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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 StatusTrial now transitioned
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