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    Summary
    EudraCT Number:2014-003277-42
    Sponsor's Protocol Code Number:MCLA-128-CL01
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-30
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2014-003277-42
    A.3Full title of the trial
    A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the investigational drug MCLA-128 which is an antibody that is
    specific to both HER2 and HER3 receptors that are associated with solid
    tumors
    A.4.1Sponsor's protocol code numberMCLA-128-CL01
    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 SponsorMerus N.V.
    B.1.3.4CountryNetherlands
    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 supportMerus N.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerus N.V
    B.5.2Functional name of contact pointMCLA-128-CL01 Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressYalelaan 62
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)30253 8802
    B.5.6E-mailm.magin@merus.nl
    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 nameNot available
    D.3.2Product code MCLA-128
    D.3.4Pharmaceutical form 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 INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeMCLA-128
    D.3.9.3Other descriptive nameA bispecific humanized full length IgG1 antibody with enhanced ADCC
    D.3.9.4EV Substance CodeSUB169257
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Solid Tumors
    E.1.1.1Medical condition in easily understood language
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term 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
    Part 1:
    - Determination of MTD/MRD and tolerability
    - Evaluation of adverse events (AEs) and dose limiting toxicities (DLT)

    Part 2:
    Primary Safety End Point:
    - To characterize the safety and tolerability of MCLA-128
    - Frequency and nature of AEs

    Primary Efficacy End Point:
    - To explore the relationships between the anti-tumor activity of MCLA-128 and disease-related biomarkers
    - Overall response rate (ORR), DOR, CBR (defined as the proportion of patients in whom a CR or PR is observed, or SD of a minimum duration of 12 weeks) per RECIST 1.1 as per local investigator’s assessment. The relationship between anti-tumor activity and biomarkers including expression of HER2, HER3, and heregulin will be explored, and serum biomarkers as
    CA-125 (ovarian) and CA-15-3 (breast).
    E.2.2Secondary objectives of the trial
    Part 1:
    - safety and tolerability of MCLA-128
    - PK profile of MCLA-128
    - Immunogenicity of MCLA-128.
    - Evaluation of anti-tumor response and CBR.
    - Frequency and nature of AEs/SAEs
    - Assessment of PK variables
    - Incidence and serum titers of anti-drug antibodies against MCLA-128.
    - Anti-tumor activity and clinical benefit assessed by RECIST v1.1 determining ORR, DOR, PFS and survival

    Part 1 - exploratory:
    - Presence of biomarkers and PD responses
    - Assessment of relevant tumor biomarkers and markers of MCLA-128 activity in archival and/or fresh tumor biopsy material and blood.

    Part 2:
    - PK profile
    - Assessment of PK variables, including total exposure, Cmax, V, Vss, t1/2, AUC0-t, AUC0-∞, tmax
    - Immunogenicity
    - Incidence and serum titers of anti-drug antibodies against MCLA-128.
    - Evaluation of PFS and overall survival, duration of response

    Part 2 – exploratory:
    - Assessment of other relevant tumor biomarkers and markers of MCLA-128 activity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria Part 1+2
    1. Age ≥18 yrs
    2. ≥1 measurable lesion, RECIST v1.1
    3. ECOG 0-1
    4. life expectancy ≥12 wks
    5. Toxicities of previous anti-cancer therapy resolved to ≤Gr 1, except for alopecia, lymphopenia assessed as non-clinically significant, Gr 2 sensory neurotoxicity
    6. ≥4-wks between last radiotherapy and D1 (except ≤1X8 Gy for pain palliation)
    7. Complete recovery from major surgery
    8. Screening Labvalues
    a. neutrophil count ≥1.5 x 10^9/L without colony stimulating factor support
    b. Platelets ≥100 x 10^9/L
    c. Hemoglobin ≥9 g/dL or ≥2.2 mmol/L (not transfusion dependent)
    d. Total bilirubin <1.5 ULN (unless Gilbert’s syndrome)
    e. AST(SGOT) ≤2.5 x ULN; ALT(SGPT) ≤2.5 x ULN; ≤5 x ULN for patients with advanced solid tumors with liver metastases; patients with confirmed bony metastases are permitted with isolated elevations in ALP >5 x ULN
    f. Serum creatinine ≤ 1.5 x ULN or estimated GFR of >50 mL/min Cockroft-Gault
    g. Coagulation function (INR and aPTT ≤1.5 ULN, unless on therapeutic anticoagulants)
    h. Urine protein dipstick ≤ 2+ ; or ≤100 mg/24 hrs urine
    9. Able to provide at baseline a mandatory archival tumor sample from fresh (preferred) or archival tissue
    10. Negative pregnancy test at Screening and ≤7 days of D1
    11. Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control during entire study and 6 months after final administration of MCLA-128
    12. give written informed consent
    13. Capable of understanding protocol requirements, is willing and able to comply with study procedures and has signed the main informed consent document. For any optional biopsy sampling (tissue and/or blood) and long-term sample storage, additional consent is required
    14. Patient with metastatic cancer who has disease progression after having received treatment with all available therapies known to convey clinical benefit

    Specific Inclusion Criterion Part 1
    15. Histologically-confirmed and documented advanced/metastatic epithelial tumors, relapsed/refractory to ≥2 prior regimens of standard treatment(s), or for which no curative therapy is available and MCLA-128 is a reasonable treatment option

    Specific Inclusion Criterion Part 2:

    Group A (BC)
    16. Histologically-confirmed and documented advanced/metastatic breast cancer (BC), relapsed/refractory to ≥2 prior HER2 directed regimen for breast cancer
    17. Confirmed HER2 amplification (HER2 2+ by IHC confirmed by FISH, or HER2 3+ by IHC) based on historical pathology report or analysis of baseline fresh/archival tumor sample

    Group B (CRC)
    18. Histologically-confirmed and documented advanced/metastatic colorectal cancer (CRC), relapsed/refractory to at least 2 prior regimens of standard treatments for metastatic CRC, including 1anti-EGFR treatment (if RASWT)
    19. Confirmed HER2 amplification based on historical pathology report prior to commencing screening assessments

    Group C (OC)
    20. Histologically-confirmed and documented advanced/metastatic epithelial ovarian cancer (OC) for which no curative therapy is available
    21. Prior therapy including all available standard therapies and ≥1 platinium based chemotherapy

    Group D (GC or GEC)
    22. Histologically-confirmed and documented advanced/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEC)
    23. Prior chemotherapy including platinium and fluoropyrimidine based treatment and trastuzumab
    24. Confirmed HER2 amplification (HER2+ by IHC confirmed by FISH, or HER3+ by IHC) based on historical pathology report or analysis of fresh/archival tumor sample

    Groupe E (EC)
    25. Histologically-confirmed and documented advanced/metastatic endometrial cancer (mEC) with no curative therapy available
    26. Prior theray with all available standard and ≥1 prior chemotherapy

    Group F (NSCLC)
    27. Histologically or cytologically documented diagnosis of Stage IIIB not amenable to radical treatment or Stage IV NSCLC; with pathological characterization of non-squamous or squamous histological subtype and adenocarcinoma subtype classification
    28. Confirmed HER2 expression (by IHC, HER2 expression 1+, 2+, 3+) on historical pathology report or analysis of baseline fresh/archival tumor sample
    29. Prior treatment included all available standard therapies with ≥1 prior regimen of platinum-based chemotherapy in locally advanced/metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment
    30. Patients with ALK fusion oncogene with documented disease progression or intolerance with a first-line ALK Tyrosine Kinase Inhibitor approved for treatment of ALK fusion oncogene NSCLC
    31. Patients with known mutation in the EGFR gene must have documented disease progression or intolerance with an EGFR TKI approved for the treatment of EGFR-mutant NSCLC
    E.4Principal exclusion criteria
    General Exclusion Criteria for Part 1 and Part 2
    1. Pregnant or lactating;
    2. Presence of an active infection or an unexplained fever greater than 38.5°C during Screening up to the first scheduled day of dosing. At the discretion of the Investigator, patients with tumor fever may be enrolled;
    3. Known hypersensitivity to any of the components of MCLA-128 or history of severe hypersensitivity reactions to human or humanized monoclonal antibodies, including therapeutic antibodies;
    4. Known HIV, Hepatitis B or Hepatitis C; patients who have previously been treated for Hepatitis C and have undetectable viral loads are eligible;
    5. Any untreated central nervous system (CNS) lesion. However, patients are eligible if: a) all known CNS lesions have been treated with radiotherapy and/or surgery and b) patient remained without evidence of CNS disease progression ≥ 4 weeks after treatment and c) patients must be off corticosteroid therapy for ≥ 3 weeks;
    6. Patients with leptomeningeal metastases
    7. Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative intent more than 2 years prior to study entry;
    8. Prior anti-tumor therapy including:
    a. Approved anti-HER2 therapies and/or anti-EGFR approved therapies within 28 days prior to the first scheduled day of dosing with MCLA-128;
    b. Investigational therapy administered within 28 days prior to the first scheduled day of dosing with MCLA-128. Dosing with MCLA-128 within 28 days of receiving investigational therapy is acceptable once a time interval equal to at least five half-lives of the investigational agent has passed or in case of prior checkpoint inhibitory treatment;
    c. Treatment with chemotherapy agents within 28 days prior to the first scheduled day of dosing with MCLA-128;
    9. Presence of NYHA Class III or IV congestive heart failure or LVEF <50% or history of significant cardiac disease, unstable angina, congestive heart failure, myocardial infarction, or ventricular arrhythmia requiring medication;
    10. Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1:
    - Determination of MTD/MRD and tolerability
    - Evaluation of adverse events (AEs) and dose limiting toxicities (DLT)

    Part 2:
    Primary Safety End Point:
    - To characterize the safety and tolerability of MCLA-128
    - Frequency and nature of AEs

    Primary Efficacy End Point:
    - To explore the relationships between the anti-tumor activity of MCLA-128 and disease-related biomarkers
    - Overall response rate (ORR), DOR, CBR (defined as the proportion of patients in whom a CR or PR is observed, or SD of a minimum duration of 12 weeks) per RECIST 1.1 as per local investigator’s assessment.The relationship between anti-tumor activity and biomarkers including expression of HER2, HER3, and heregulin will be explored and serum biomarkers as
    CA-125 (ovarian) and CA-15-3 (breast).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Tumor assessment at Screening (up to 28 days prior to Cyc 1 D1), end of every two cycles: (Cyc 2 D21, Cyc 4 D21, Cyc 6 D21, Cyc 8 D21…) until end of treatment, FSV, LTF
    - AEs recorded at Cyc 1 D1, D2 - 4, D8, D15; Cyc 2-4 D1, D8 D15, D21; Cyc 5 onwards D1, D15, D21; EOT; FSV
    E.5.2Secondary end point(s)
    Part 1:
    - To characterize the safety and tolerability of MCLA-128
    - PK profile of MCLA-128
    - Immunogenicity of MCLA-128.
    - Evaluation of anti-tumor response and CBR.
    - Frequency and nature of AEs/serious adverse events (SAEs).
    - Assessment of PK variables, including total exposure, maximum concentration (Cmax) clearance, volume of distribution (V), volume of distribution at steady state (Vss), half-life (t1/2), AUC0-t (area under the concentration versus time curve from time zero to time t), AUC0-∞ (area under the concentration versus time curve), tmax (time to reach maximum concentration).
    - Incidence and serum titers of anti-drug antibodies against MCLA-128.
    - Anti-tumor activity and clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR), duration of response (DOR), progression-free survival (PFS) and survival; CBR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR) or stable disease (SD) is observed (where SD duration is a minimum of 12 weeks).

    Part 1 - exploratory:
    - Presence of biomarkers and pharmacodynamic (PD) responses to MCLA-128.
    - Assessment of relevant tumor biomarkers and markers of MCLA-128 activity in archival and/or fresh tumor biopsy material and blood. The following candidate biomarkers will be assessed:
    o HER2, HER3, pHER2, pHER3 and heregulin;
    o KRAS, NRAS, PIK3CA, BRAF mutation status (metastatic colorectal cancer (mCRC) patients only);
    o circulating tumor deoxyribonucleic acid (DNA) and mutations in genes associated with HER2/HER3 signaling;
    o phosphorylated molecules in the MAPK and AKT signaling pathway.


    Part 2:
    - PK profile of MCLA-128
    - Assessment of PK variables, including total exposure, Cmax, V, Vss, t1/2, AUC0-t, AUC0-∞, tmax.
    - Immunogenicity of MCLA-128
    - Incidence and serum titers of anti-drug antibodies against MCLA-128.
    - Evaluation of PFS and overall survival, duration of response

    Part 2 - exploratory:
    - Assessment of other relevant tumor biomarkers and markers of MCLA-128 activity in archival and/or fresh tumor sample/biopsy material and blood.
    - The following candidate biomarkers will be assessed if sufficient sample is available:
    Tumor sample:
    o pHER2, pHER3, HER2:HER3 dimerization;
    o Heregulin and (depending on availability) mutations in genes associated with HER2 and HER3
    o Phosphorylated molecules in the MAPK and AKT signaling pathway.
    o Heregulin-gene fusions (in case of a validated assay

    Blood:
    o CD16 (Fcgamma receptor polymorphism)
    o Circulating tumor DNA and mutation analysis in genes associated with HER2/HER3 signaling;
    o Circulating Tumor Cells for HER2
    E.5.2.1Timepoint(s) of evaluation of this end point
    - PK assessed at Cyc 1 D1, D2 - 4, D8, D15; Cyc 2-4 D1
    - Immunogenicity assessed at Cyc 1 D1; Cyc 2-4 D1; EOT; FSV
    - Biomarker/PD: Biopsy assessed at Screening (up to 28 days prior to Cyc 1 D1), end of Cyc 2-4, EOT; Blood assessed at Cyc 1 D1 (pre-dose), end of Cyc 2-4, end of every fourth cycle starting cycle 5 and EOT
    - Tumor assessment at Screening (up to 28 days prior to Cyc 1 D1), end of every two cycles: (Cyc 2 D21, Cyc 4 D21, Cyc 6 D21, Cyc 8 D21…) until end of treatment, FSV, LTF
    - AEs recorded at Cyc 1 D1, D2 - 4, D8, D15; Cyc 2-4 D1, D8 D15, D21; Cyc 5 onwards D1, D15, D21, EOT, FSV
    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 Yes
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part 2 is parallel design, Part 1 is not
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    France
    Italy
    Netherlands
    Portugal
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 142
    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 188
    F.4.2.2In the whole clinical trial 228
    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 in both Parts 1 and 2 of the study may remain on treatment until disease progression, death, unacceptable toxicity, or discontinuation for any other reason. Following study completion, patients will be followed up every 3 months for up to 2 years (approximately) to check their disease and/or survival status and commencement of their next anticancer treatment. In case of treatment termination the investigator will discuss next treatment options outside of this study.

    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 Decision2017-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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