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    Summary
    EudraCT Number:2020-002103-19
    Sponsor's Protocol Code Number:CTL-002-001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-002103-19
    A.3Full title of the trial
    A Phase 1/2, first-in-human, two-part, open-label clinical trial of intravenous administration of CTL-002 given as monotherapy and/or in combination with an anti-PD-1 checkpoint inhibitor in subjects with advanced-stage, relapsed/refractory solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 FIH trial of CTL-002 in subjects with advanced-stage, relapsed/refractory solid tumors.
    A.4.1Sponsor's protocol code numberCTL-002-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04725474
    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 SponsorCatalYm GmbH
    B.1.3.4CountryGermany
    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 supportCatalYm GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCatalYm GmbH
    B.5.2Functional name of contact pointPetra Fettes
    B.5.3 Address:
    B.5.3.1Street AddressAm Klopferspitz 19
    B.5.3.2Town/ cityPlanegg-Martinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989200066451
    B.5.6E-mailpetra.fettes@catalym.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.3.2Product code CTL-002
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameCTL-002
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.2.1.1.1Trade name Opdivo®
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Company, USA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameOPDIVO 10 mg/mL concentrate for solution for infusion
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Advance-stage, relapsed/refractory solid tumors in non-curable state, that relapsed post or were refractory to a prior anti-PD-1/PD-L1 therapy.
    E.1.1.1Medical condition in easily understood language
    Advanced-stage, relapsed/refractory 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 LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    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 B: To explore the preliminary anti-tumor activity of CTL-002 administered in combination with an anti-PD-1 checkpoint inhibitor in in subjects with advanced-stage relapsed/refractory solid tumors in non-curable state as per current clinical knowledge that have either (1) bladder CA, hepatocellular CA, non-small cell lung cancer or melanoma (for melanoma, only cutaneous and mucosal forms, not uveal/ocular) (approved anti-PD-1/PD-L1 indications) that relapsed on or were primary refractory to prior anti-PD-1/PD-L1 therapy with an approved anti-PD-1/PD-L1 compound and have exhausted all available approved standard treatments or are not eligible for them anymore, or (2) CRC (micro-satellite stable [MSS]/mismatch-repair competent) and have not received any prior anti-PD-1/PD-L1 therapy, or (3) biomarker cohort with mixed solid tumors that relapsed or were primary, anti-PD-1/PD-L1 therapy
    Note: The colorectal cancer cohort is not applicable for Germany.
    E.2.2Secondary objectives of the trial
    PART A:
    - To explore the pharmacokinetics (PK) of CTL-002 administered as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor.
    - To explore the pharmacodynamics of CTL-002 administered as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor.
    - To determine the recommended dose(s) for the expansion cohorts (Part B [expansion]) of CTL-002 administered as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor.
    - To explore the preliminary anti-tumor activity of CTL-002 administered in combination with an anti-PD-1 checkpoint inhibitor.
    - To explore the effect of CTL-002 on prevention of anorexia and muscle wasting (cachexia).
    PART B:
    - To confirm and further explore the PK/pharmacodynamics of CTL-002 given in combination with an anti-PD-1 checkpoint inhibitor.
    - To confirm the recommended Phase 2 dose (RP2D) of CTL-002.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening:
    1.Provide signed and dated informed consent. For Part A only: signed pre-screening consent for patients that undergo pre-screening procedures
    2. Male or female aged ≥ 18 years.
    3.Subjects with histologically or cytologically confirmed/documented diagnosis of advanced-stage, relapsed/refractory solid tumors in non-curable state as per current clinical knowledge who have exhausted all available approved standard treatments or are not eligible for them anymore.
    4. For Part A (Ph 1), subjects must have received during their prior treatment at least one anti-PD-1/PD-L1 treatment (alone or in combination) and progressed on or relapsed after completion of the anti-PD-1/PD-L1 treatment (with a minimum of 12 weeks of anti-PD1/PD-L1 exposure).
    For Part B (Ph 2a), subjects must either have (1) bladder CA, hepatocellular CA, non-small cell lung cancer, or melanoma (for melanoma, only cutaneous and mucosal forms, not uveal/ocular) (approved anti-PD-1/PD-L1 indications) that relapsed on or were primary refractory to prior anti-PD-1/PD-L1 therapy with an approved anti-PD-1/PD-L1 compound (with a minimum of 12 weeks of anti-PD-1/PD-L1 exposure), and have exhausted all available approved standard treatments or are not eligible for them anymore (2) CRC (MSS/mismatch-repair competent) and have not received any prior anti-PD-1/PD-L1 therapy. (Note: Not applicable in Germany), or (3) biomarker cohort with mixed solid tumors (”basket” cohort;) that relapsed or were primary refractory to prior anti PD-1/PD-L1 therapy with an approved anti-PD-1/PD-L1 compound and have exhausted all available approved standard treatments or are not eligible for them anymore. Note: All Subjects in cohorts (1) and (3) must have received an approved anti-PD-1/PD-L1 compound with a minimum of 12 weeks of anti-PD1/PD L1 exposure. Non-approved, experimental anti-PD-1/PD-L1 treatments are not permissive for enrolment into this group.
    5.Ability to understand the purpose of the study, provide signed and dated informed consent prior to performing any protocol-related procedures (including Screening evaluations)
    6. For Part A, ideally ~50% of subjects enrolled per dose level should have increased GDF-15 serum levels [based on pre-screening result or historic serum GDF-15 data (up to 2 months prior to the start of treatment with CTL-002 where available)].
    7.All subjects must have biopsy-accessible tumor lesions and be willing to undergo tumor biopsy: triple-sequential biopsies (Part A) or dual-sequential biopsies (Part A backfill); in Part B, baseline biopsy (new or archived if obtained within 120 days prior to treatment start) from all subjects. In the melanoma, and the biomarker cohort with mixed solid tumors (“basket” cohort), an additional on-treatment biopsy is mandatory. All biopsies are mandatory unless not seen as safe and feasible by the treating physician or another specific reason that precludes a biopsy sample being taken and which should be discussed with the Medical Monitor prior to Screening or if applying to the sequential biopsy, prior to that biopsy. All other study eligibility criteria must be met before the baseline biopsy sample is obtained. (Important note for the biomarker cohort: in case biopsy cannot be taken for medical reasons and no archived biopsy <120 days is available, subject cannot be included.
    8. For Part B, presence of radiologically measurable disease at baseline – with at least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI and is suitable for accurate, repeated measurements as per RECIST V1.1/imRECIST is required. This shall not be the lesion that is going to be biopsied.
    9. ECOG 0-1.
    10. Life expectancy > 3 months
    11. Adequate organ function. Note: D-Dimer elevation by itself does not preclude inclusion if no clinical evidence of thrombosis is present.
    12. All toxicities related to prior radiotherapy, chemotherapy, any type of immunotherapy or other anti-cancer therapy, or surgical procedure must have recovered to Grade ≤ 1 based on NCI-CTCAE v5.0, except alopecia (any grade), Grade 2 peripheral sensory neuropathy, and AEs that are clinically not considered as significant in this context and/or are stable on supportive therapy.
    13. If subject has type II diabetes and receives metformin, metformin has to be replaced with other antidiabetic(s) prior to start of study treatment (at minimum 7 days prior to study baseline GDF-15 measurement) and for the whole study treatment duration.
    14. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to CTL-002 treatment.
    15. Women of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months.
    For full list of IC please refer to the Protocol
    E.4Principal exclusion criteria
    1. Pregnant or breastfeeding.
    2. Has received any tumor-directed therapy within 21 days before start of study treatment.
    3. Treatment with any investigational agent within 21 days before start of study treatment.
    4. Radiotherapy within 14 days before the start of the study treatment; however, subjects may receive palliative radiotherapy upon discussion and approval from the Medical Monitor if needed on non-target lesions.
    5. Any acute or chronic major tissue injury that may require maintained GDF-15 function for tissue protection as per Investigator assessment (diagnosed with liver, kidney, myocardial infarction, or other major organ failure, all within < 6 months prior to Screening).
    6. Pre-existing arrhythmia (unless considered clinically not relevant), uncontrolled angina pectoris, diagnosed with heart failure New York Heart Association (NYHA) Grade IV, any myocardial infarction/coronary event as well as any central nervous system (CNS)-ischemic event and any thromboembolic event at any time < 6 months prior to Screening or presence of uncontrolled heart failure NYHA Grade III or higher
    7. Left ventricular ejection fraction (LVEF) < 50% as measured by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan if ECHO cannot be performed at site for any reason
    8. QT interval corrected for heart rate using Fridericia’s formula (QTcF) interval > 450 ms for men or > 470 ms for women.
    9. Any active autoimmune disease that requires systemic immunosuppressive treatments, for which (re-)activation may present a medical threat to the subject as per Investigator’s assessment
    10. Any history of non-infectious pneumonitis < 6 months prior to Screening.
    11. Any active inflammatory bowel disease such as Crohn’s disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present < 6 months prior to Screening.
    12. Type I diabetes.
    13. History of CNS disease such as stroke, seizure, encephalitis, or multiple sclerosis (< 6 months prior to Screening).
    14. Any history of motor neuron disorder or disease that affects motor neuron function.
    15. Ongoing immune-related AEs (irAEs) and/or AEs ≥ Grade 2 not resolved from previous therapies except vitiligo, stable peripheral sensory neuropathy up to Grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.
    16. Active allergy requiring systemic treatment (with the exception of histamine H1 receptor blocker treatment) or active infections requiring systemic anti-infectious therapy.
    17. History of or clinical evidence of CNS primary tumors or metastases including leptomeningeal metastases, unless they have been previously treated, demonstrated no progression at least for 3 months before Screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening – subjects with suspected brain metastases at Screening should undergo a CT/MRI of the brain prior to study entry.
    18. Systemic steroids at a daily dose of > 10 mg of prednisolone, > 2 mg of dexamethasone or equivalent, except non-systemic (inhaled, topical, nasal), for the last 28 days and ongoing.
    19. Subjects with rapidly progressing disease (as per Investigator assessment), which may predispose to inability to tolerate treatment and/or study procedure.
    20. Major surgery within last 4 weeks prior to Screening.
    21. Known/expected hypersensitivity against CTL-002 and/or anti-PD-1/PD-L1 agents or their ingredients or previously had a severe hypersensitivity (≥ Grade 3) reaction to treatment with monoclonal antibodies (including pembrolizumab, nivolumab, cemiplimab etc.) and/or any of their excipients.
    22. Evidence for active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), tuberculosis (TB), or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as per adequate testing performed.
    23. Dementia or altered mental status that would prohibit informed consent.
    24. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory abnormality giving reasonable suspicion of a disease or condition that in the opinion of the Investigator would contraindicate the use of an investigational drug.
    25. Receipt of any organ transplantation, including hematopoietic cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).
    26. Paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or a clinical symptomatology suggesting worsening of PNS
    27. Vaccine administration within 4 weeks of investigational drug administration (exception: coronavirus disease 2019 (COVID-19) vaccination). Vaccination with live vaccines while on trial is prohibited......
    For full list of exclusion criteria please refer to the Protocol
    E.5 End points
    E.5.1Primary end point(s)
    PART A:
    - Evaluation of the number of subjects with adverse events (AEs), including serious adverse events (SAEs), clinical laboratory data, vital signs, electrocardiograms (ECGs), physical examination (including neurological assessment) and Eastern Cooperative Oncology Group (ECOG) performance status.
    - Determination of dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) in Part A of the study using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

    PART B:
    - Evaluation of the clinical efficacy according to RECIST V1.1 of CTL-002 in combination with an anti-PD-1 checkpoint inhibitor by assessment of:
    o The proportion of subjects with tumor shrinkage, a confirmed partial response (PR) and/or complete response (CR), and overall response rate (ORR).
    o The interval between the date of first CTL-002 administration and first documented evidence of a PR or CR (time to response [TTR]).
    o The interval between the date of first documented evidence of PR or CR, until first documented evidence of disease progression or death, due to any cause (duration of response [DOR]).
    o The interval between the date of first CTL-002 administration and the earliest date of disease progression or death (progression free survival [PFS]).
    o The interval between the date of first CTL-002 administration and date of death due to any cause (overall survival [OS]).
    - Evaluation of the number of subjects with AEs, including SAEs, clinical laboratory data, vital signs, ECGs, physical examination (including neurological assessment), and ECOG performance status.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to Schedule of Assessments
    E.5.2Secondary end point(s)
    PART A:
    - Evaluation of PK parameters of CTL-002 (e.g., maximum concentration [Cmax], area under the curve [AUC], and half-life [t1/2]).
    - Evaluation of treatment-emergent cytokine profiles in peripheral blood.
    - Evaluation of treatment-induced anti-drug antibodies (ADA).
    - Evaluation of the clinical efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of CTL-002 as monotherapy and in combination with an anti-PD-1 checkpoint inhibitor by assessment of:
    o The proportion of subjects with tumor shrinkage, a confirmed partial response (PR) and/or complete response (CR), and overall response rate (ORR).
    o The interval between the date of first CTL-002 administration and first documented evidence of a PR or CR (Time to Response [TTR]).
    o The interval between the date of first documented evidence of PR or CR, until first documented evidence of disease progression or death, due to any cause (Duration of Response [DOR]).
    o The interval between the date of first CTL-002 administration and the earliest date of disease progression or death (Progression Free Survival [PFS]).
    o The interval between the date of first CTL-002 administration and date of death due to any cause (Overall Survival [OS]).
    - To assess appetite, body mass index (BMI), and muscle mass (e.g., L3 skeletal muscle index [L3SMI]).

    PART B:
    Secondary Endpoints:
    - Evaluation of PK parameters of CTL-002 (e.g., Cmax, AUC and t1/2).
    - Evaluation of treatment-emergent cytokine and chemokine profiles in peripheral blood.
    - Evaluation of treatment-induced ADA.
    - Evaluation of GDF-15 baseline serum levels and their correlation with pharmacodynamics and clinical response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to Schedule of Assessments
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    United Kingdom
    United States
    Germany
    Italy
    Spain
    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
    The end of the core study is defined as the time point when the last
    subject has completed the last Safety Follow-up Visit (End of Core
    Study Visit) 30 days from the last dose.
    The end of study is defined as the time point when the last subject has
    completed the last Efficacy and Survival follow-up. This is 12 months
    after end of the core study for Part A and 24 months after end of the
    core study for Part B.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 238
    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)
    Return to standard of care.
    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 Decision2020-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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