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    Summary
    EudraCT Number:2021-000707-20
    Sponsor's Protocol Code Number:AFM24-102
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-07
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-000707-20
    A.3Full title of the trial
    A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR-expressing Cancers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2a study of AFM24 and Atezolizumab in patients with advanced and metastatic cancers
    A.4.1Sponsor's protocol code numberAFM24-102
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05109442
    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 SponsorAffimed 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 supportAffimed GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAffimed GmbH
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressGottlieb-Daimler-Straße 2
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68165
    B.5.3.4CountryGermany
    B.5.4Telephone number+49621 56003 621
    B.5.5Fax number+49621 56003 649
    B.5.6E-mailAFM24-102-Clinical@affimed.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 nameAFM24
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAFM24
    D.3.9.3Other descriptive nameAFM24
    D.3.9.4EV Substance CodeSUB203845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameTecentriq
    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 INNATEZOLIZUMAB
    D.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeATEZOLIZUMAB
    D.3.9.3Other descriptive nameATEZOLIZUMAB
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number840
    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: 3
    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 nameAFM24
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAFM24
    D.3.9.3Other descriptive nameAFM24
    D.3.9.4EV Substance CodeSUB203845
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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/Metastatic EGFR-expressing Cancers
    E.1.1.1Medical condition in easily understood language
    Advanced/Metastatic Cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced 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
    Dose Escalation Phase (Phase 1):
    -To determine the maximum tolerated dose (MTD) and/or to select one or more recommended phase 2 doses (RP2Ds) of AFM24 in combination with atezolizumab.

    Phase 2a:
    -To evaluate the antitumor activity of AFM24 in combination with atezolizumab in terms of ORR.
    E.2.2Secondary objectives of the trial
    Dose Escalation Phase (Phase 1):
    - To assess the safety and tolerability of AFM24 in combination with atezolizumab
    - To evaluate the preliminary antitumor activity of AFM24 in combination with atezolizumab in terms of objective response rate (ORR)
    - To characterize the pharmacokinetic (PK) profile of AFM24 when AFM24 is given in combination with atezolizumab
    - To assess the immunogenicity of AFM24 when AFM24 is given in combination with atezolizumab.

    Phase 2a:
    - To assess preliminary efficacy of AFM24 in combination with atezolizumab using additional measures of clinical benefit
    - To assess the safety and tolerability of AFM24 in combination with atezolizumab
    - To characterize the PK profile of AFM24 when AFM24 is given in combination with atezolizumab
    - To assess the immunogenicity of AFM24 when AFM24 is given in combination with atezolizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Voluntary provision and understanding of signed and dated, written informed consent prior to any mandatory study-specific procedures, sampling, or analysis.
    2) Patients must be aged ≥18 years on the day of signing informed consent (or of an acceptable age according to local regulations, whichever is older).
    3) Patients must have documented radiological progression during or after their latest therapy for all phases.
    4) Patients have documented histologically or cytologically confirmed advanced or metastatic EGFR-positive (positive staining for EGFR in ≥1% of tumor cells determined by a locally validated immunohistochemistry assay) select cancer types, except for NSCLC
    patients (cohorts EXP-1 and EXP-4), and meet the following criteria:
    Dose Escalation Phase (Phase 1):
    Dose Escalation Cohorts: Patients who meet the criteria specified for the expansion cohorts.
    Expansion phase (Phase 2a):
    -EXP-1: patients with advanced or metastatic, EGFR WT expressing NSCLC whose disease has progressed after having received ≥1 prior lines of therapy for advanced disease.
    -EXP-2: patients with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy.
    -EXP-3: patients with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Archived paraffin-embedded tumor tissue is acceptable for EGFR determination, otherwise a fresh tumor biopsy must be performed.
    -EXP-4: patients with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥1 prior lines of therapy for advanced disease including ≥1 prior TKI approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib.
    5) ECOG Performance Status (PS) 0 or 1
    6) Adequate organ function as determined by:
    a. Hematological
    i. Absolute neutrophil count (ANC) ≥1.5×10^9/L (1,500/mm3)
    ii. Platelet count ≥75×10^9/L (75,000/mm3)
    iii. Hemoglobin ≥ 9 g/dL.
    b. Hepatic: Total bilirubin ≤1.5 × ULN or ≤3 × ULN in participants with Gilbert's syndrome, ALT and AST ≤2.5×ULN for patients without liver metastasis and ALT and AST ≤5×ULN for patients with liver metastasis or hepatocellular carcinoma (HCC). Albumin >3.0 g/dL. For HCC, Child-Pugh score <7 (Child-Pugh Class A) (APPENDIX H for details for the Child-Pugh Score classification).
    c. Renal: Serum creatinine ≤1.5 × ULN OR Measured or calculated creatinine clearance ≥ 60 mL/min for patients with creatinine levels > 1.5 × institutional ULN.
    d. INR or PT or aPTT ≤ 1.5 × ULN unless patient is receiving anticoagulant therapy, in which case PT/aPTT must be within therapeutic range for intended use of anticoagulants.
    Note: no growth factor or transfusion support within 7 days of testing allowed; and patients must be reassessed on or within 7 days of the first AFM24 infusion [i.e., Day -7] to remain eligible
    7) Serum potassium, calcium, magnesium, and phosphate within normal limits or not worse than CTCAE v5.0 Grade 1 and asymptomatic.
    8) Patients with inactive/asymptomatic carrier, chronic, or active hepatitis B virus (HBV) infection must meet the following criteria: HBV deoxyribonucleic acid (DNA) <500 IU/mL (or 2500 copies/mL) at screening.
    Patients with cured hepatitis C virus (HCV) infection at screening can be enrolled.
    9) Patients must have evaluable or measurable disease per RECIST v1.1 for the dose escalation phase (Phase 1). For the expansion phase (Phase 2a), patients must have measurable disease by RECIST v1.1.
    10) Female patients of childbearing potential must have a negative urine or serum pregnancy test at Screening and prior to first AFM24 infusion (i.e., Day -7) to be eligible in this study.
    11) Females of childbearing potential must agree to sexual abstinence or be willing to use a highly effective method of contraception for the course of the study from 14 days prior to the first dose of study drug through 5 months after the last dose of study drug.
    12) Males who have female partners of childbearing potential must agree to use a highly effective method of contraception starting with the first dose of study therapy through 5 months after the last dose of study drug.
    E.4Principal exclusion criteria
    1) Currently receiving active treatment in any other clinical study, or administration of other investigational agent.
    2) Treatment with any systemic anticancer therapy including investigational agent within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indication. Anticancer therapies include cytotoxic chemotherapy, targeted inhibitors, and immunotherapies, but do not include hormonal therapy or radiotherapy for bone metastases >2 weeks prior to first AFM24 infusion (i.e.,Day-7).
    3) Radiation therapy within 4 weeks before first dose of study drug (with the exception of limited palliative radiotherapy) or unresolved (CTCAE v5.0 >Grade 1) toxicity from previous radiotherapy (e.g. radiation dermatitis).
    4) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day -7 or anticipation of need for a major surgical procedure during the course of the study.
    5) Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to first AFM24 infusion (i.e. D-7).
    6) Patients with toxicities (because of prior anticancer therapy) which have not recovered to baseline or CTCAE v5.0 ≤ Grade 1, except for AEs not considered a likely safety risk (e.g. alopecia, neuropathy, specific laboratory abnormalities).
    7) History of interstitial lung disease, or non-infectious pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening.
    8) History of any other invasive malignancy, unless previously treated with curative intent and the patient has been disease free for 3 years or longer. Acceptable previous malignancies include completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, and early-stage prostate cancer that has been adequately treated.
    9) Untreated or symptomatic central nervous system metastases including leptomeningeal disease or spinal cord compression.
    10) One or more of the following cardiac criteria:
    a. Unstable angina;
    b. Myocardial infarction within 6 months prior to screening;
    c. NYHA Class III and IV heart failure;
    d. Corrected QT interval >470 msec obtained as the mean from 3 consecutive resting ECGs using the Fridericia’s formula;
    e. Clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;
    f. Congenital long QT syndrome;
    g. Uncontrolled hypertension despite maximum antihypertensive therapy.
    11) Stroke or transient ischemic attack within 6 months prior to screening.
    12) Has received a live vaccine administered within 28 days of planned treatment start (i.e. Day -7) or while participating in the study.
    13) Diagnosis of immunodeficiency or active infection including known HBV, HCV, or HIV.
    14) A known history or autoimmune disease requiring systemic immunosuppressive therapy; or any disease process requiring systemic immunosuppressive therapy (such as high-dose steroids defined as ≥10 mg prednisone or equivalent per day) within 4 weeks prior to the first
    dose of AFM24.
    Exceptions:
    -Topical (≤20% of the skin surface area), ocular, intra-articular, intranasal, or inhalation corticosteroids with minimal systemic absorption
    -Short Course (≤7 days) of corticosteroids prescribed prophylactically or for treatment of a non-autoimmune causes
    -Physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency
    15) Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with 14 days before the first dose of study treatment (i.e. Day -7) through 5 months after the last dose of study drug.
    16) Patient’s unwillingness to comply with the protocol or inability to
    appreciate the nature, meaning, and consequences of the study and to formulate his/her own wishes correspondingly.
    17) Known hypersensitivity to monoclonal antibodies or any components used in the AFM24 or atezolizumab drug product preparations and any history of anaphylaxis; or uncontrolled asthma.
    18) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic antibacterial, antifungal, or antiviral 2 weeks before the first dose of AFM24 infusion (on Day -7), decompensated cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.
    19) 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, or is not in the best interest of the patient to participate.
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation Phase (Phase 1):
    -Adverse events (AEs) to be assessed by the incidence and severity of dose-limiting toxicity (DLT) within the DLT observation period (Cycle 1)

    Phase 2a
    -ORR according to RECIST v1.1 determined by the Investigator assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dose Escalation Phase (Phase 1):
    ≤28 days following the first dose of AFM24 in combination with
    atezolizumab (Cycle 1).

    Phase 2a:
    For screening, radiographic tumor assessment is allowed up to 28 days prior to first
    dose of AFM24 on Day -7.
    CT or MRI will be done at Screening and during the last week of Cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter.
    E.5.2Secondary end point(s)
    Dose Escalation Phase (Phase 1):
    - Incidence of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
    - ORR using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 determined by Investigator assessment
    - PK parameters of AFM24: Cmax, Tmax, Cmin and AUCtau
    - Frequency of patients developing anti-drug antibodies (ADAs) against AFM24

    Phase 2a:
    - Progression-free survival (PFS) according to RECIST v1.1 by Investigator assessment
    - Duration of response (DOR) according to RECIST v1.1 by Investigator assessment
    - Clinical benefit rate (CBR) according to RECIST v1.1 by Investigator assessment
    - Disease control rate (DCR) according to RECIST v1.1 by Investigator
    assessment
    - Incidence of patients with TEAEs and SAEs
    - PK parameters of AFM24: Cmax, Tmax, Cmin, and AUCtau
    - Frequency of patients developing ADAs against AFM24
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per the Protocol Schedule of assessments (Tables 7- 14)
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Assessment of the safety, tolerability, PK, and efficacy of the combination AFM24 plus Atezolizumab
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Korea, Republic of
    United Kingdom
    United States
    Poland
    Spain
    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 study will be terminated as soon as the last patient ending treatment has completed the first long-term follow-up interval.
    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 months1
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 89
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 59
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 148
    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)
    None
    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 Decision2022-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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