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    Summary
    EudraCT Number:2021-000203-20
    Sponsor's Protocol Code Number:MCLA-129-CL01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000203-20
    A.3Full title of the trial
    Phase 1/2 dose escalation and expansion study evaluating MCLA-129, a human anti-EGFR and anti-c-MET bispecific antibody, in patients with advanced NSCLC and other solid tumors.
    Fase 1/2 dosisescalatie- en uitbreidingsstudie ter beoordeling van MCLA-129, een humaan bispecifiek anti-EGFR- en anti-c-MET-antilichaam, bij patiënten met gevorderde NSCLC en andere solide tumoren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of MCLA-129 in patients with NSCLC and other solid tumors.
    Fase 1/2-onderzoek van MCLA-129 bij patiënten met NSCLC en andere solide tumoren.
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberMCLA-129-CL01
    A.5.4Other Identifiers
    Name:-Number:-
    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-129-CL01 Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressUppsalalaan 17, 3rd & 4th floor
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31611 28 87 94
    B.5.6E-mailG.laus@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.3.2Product code MCLA-129
    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 INNMCLA-129
    D.3.9.2Current sponsor codeMCLA-129
    D.3.9.3Other descriptive nameMCLA-129
    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
    advanced NSCLC and other solid tumors
    gevorderde NSCLC en andere solide tumoren
    E.1.1.1Medical condition in easily understood language
    advanced NSCLC and other solid tumors
    gevorderde NSCLC en andere solide tumoren
    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 PT
    E.1.2Classification code 10061873
    E.1.2Term 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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    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
    Phase 1 Dose escalation
    Primary Objective
    • To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.

    Phase 2 Dose expansion
    Primary Objective
    • To evaluate the clinical activity, as assessed by ORR of MCLA-129 alone or in combination with an EGFR or c-MET TKI in populations of advanced/metastatic solid tumors.
    E.2.2Secondary objectives of the trial
    Phase 1 Dose escalation
    Secondary Objectives
    • To evaluate preliminary antitumor activity in terms of best overall response (BOR), overall response rate (ORR), disease control rate (DCR), and duration of response (DoR).
    • To evaluate progression-free survival (PFS) and overall survival (OS).
    • To characterize the pharmacokinetics (PK) of MCLA-129 including development of a population PK model.
    • To assess changes in cytokines following administration of MCLA-129.
    • To assess the immunogenicity of MCLA-129.
    • To assess the overall safety and tolerability of MCLA-129.

    Phase 2 Dose expansion
    Secondary Objectives
    • To evaluate preliminary antitumor activity in terms of BOR, DCR, and DoR.
    • To evaluate PFS and OS.
    • To characterize the safety and tolerability of MCLA-129 at the RP2D.
    • To characterize the PK of MCLA-129 including development of a population PK model.
    • To assess the immunogenicity of MCLA-129.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent before initiation of any study procedure.s.
    2. Age ≥ 18 years at signature of informed consent.
    3. Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced unresected disease that is incurable:

    Dose Escalation Part - Patients who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens. Patients must have:
    - Non-small cell lung cancer (NSCLC) harboring activating EGFR mutations including tyrosine kinase inhibitor (TKI) sensitizing mutations (e.g., 19del and L858R), and/or approved TKI-resistance mutations (e.g., acquired TKI-resistance mutations, i.e., T790M, C797S, L792, L798I, exon 20 insertion), or any activating c-MET mutation/amplification (e.g., high-level c-MET amplification [MET/CEP7 > 5 or cfDNA ≥ 2 copies], or c-MET exon 14 skipping mutation).
    - Gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma harboring an EGFR amplification (EGFR/CEP7 ≥2 or cfDNA ≥ 8 copies) or c-MET amplification (MET/CEP7 > 5 or cfDNA ≥ 2 copies).
    - Head and neck squamous cell cancer (HNSCC) or esophageal squamous cell cancer (ESCC).

    Dose Expansion Part - Patients must have:
    • Cohort A:
    - NSCLC harboring an EGFR exon 20 insertion, that has progressed after platinum doublets (a limited number of first line patients can be included)
    • Cohort B:
    - NSCLC harboring c-MET exon 14 skipping mutation ≥2L
    - Naive or pretreated to capmatinib and tepotinib
    • Cohort C:
    - Selected solid tumors (GC/GEJ/pancreas/ESCC, GBM and PRCC) harboring an EGFR or c-MET alteration
    - NSCLC patients with other EGFR/c-MET alterations, not otherwise included in the other cohorts
    - Patients must have exhausted or be intolerant to all approved therapies with rationale for clinical benefit with MCLA-129
    • Cohort C1:
    - HNSCC refractory to approved treatment (regardless of driver mutations)
    • Cohort D:
    - NSCLC 1L harboring EGFR sensitizing mutations (i.e. Del19, L858R)
    • Cohort E:
    - NSCLC osimertinib resistant (participant must have progressed on or after a previous osimertinib monotherapy)
    *NOTE: Patient identification will be based on previous treatment history with TKIs, on local tests performed in CLIA-certified laboratories or on commercial diagnostics (e.g., FoundationOne). Genetic aberrations in EGFR or c-MET will be retrospectively confirmed by central testing using a validated assay in the expansion phase. For non-first line cohorts there is no limit to the number of prior treatment regimens.

    4. Availability of tissue sample FFPE embedded after progression at the latest therapy (preferred in escalation, mandatory in expansion). Archival tumor tissue collected in the past may also be taken into consideration, but it is not preferred.
    5. Measurable disease as defined by RECIST version 1.1 by radiologic methods (patients with non-measurable but evaluable disease can be included in the dose escalation part).
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    7. Life expectancy ≥ 12 weeks, as per Investigator judgment.
    8. Adequate organ function, as per Investigator judgment
    • Absolute neutrophil count (ANC) ≥1.5 X 109/L
    • Hemoglobin ≥9 g/dL
    • Platelets ≥100 x 109/L
    • Corrected total serum calcium within normal ranges
    • Serum magnesium within normal ranges (or corrected with supplements)
    • Serum potassium within normal ranges
    • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN (patients with Gilbert’s syndrome are eligible if conjugated bilirubin value is within normal limits); in cases of liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed
    • Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min calculated according to the Cockcroft and Gault formula or MDRD formula for patients aged >65 years. If either value is not met, patient cannot be enrolled in the study.
    • Serum albumin >3.3 g/dL
    E.4Principal exclusion criteria
    1. Central nervous system metastases that:
    -are untreated or symptomatic (patients with untreated, asymptomatic lesions can be included if in the investigator judgment considered clinically & radiologically stable)(exp. phase only)
    -require radiation or surgery(exp. phase only)
    -require continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry
    2. Known leptomeningeal involvement(exp. phase only)
    3. Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
    5. Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives,whichever is shorter, of the first dose of study drug.For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks required. Note: For agents with long half-lives, enrollment before the fifth half-life requires Sponsor approval. Cohort E patients can continue to receive osimertinib, as last treatment.
    6. Major surgery or radiotherapy within 3 weeks of the first dose. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible. Patients who received radiotherapy on lung at any time are not eligible.
    7. Persistent Grade >1 clinically significant toxicities, in Investigator judgment, related to prior antineoplastic therapies (except alopecia); stable sensory neuropathy ≤ Grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ Grade 2 which is stable on hormone replacement are allowed.
    8. History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents.
    9. History of clinically significant cardiovascular disease including, but not limited to:
    • Prolonged QT interval > 470 msec, obtained from 3 electrocardiograms, or clinically significant cardiac arrythmia, conduction or morphology of resting ECG (ie., complete left bundle branch block, third degree heart block and second degree heart block), or electrophysiologic disease (i.e., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate) or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities. Patients with cardiac pacemakers who are clinically stable are eligible.
    • Heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years in first-degree relatives or concomitant medication known to prolong QT interval and cause Torsades de Pointes.
    • Uncontrolled (persistent) arterial hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 100 mm Hg.
    • Congestive heart failure defined as New York Heart Association class III-IV or hospitalization for CHF within 6 months of the first dose.
    10. Past medical history of interstitial lung disease (ILD) or pneumonitis, or any evidence of clinically active ILD or pneumonitis.
    11. History of interstitial lung disease including drug-induced interstitial lung disease, radiation pneumonitis that requires treatment with prolonged steroids or immune suppressive agents within 1 year.
    11. Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety & efficacy of the study drug(exp. phase only).
    13. Current serious illness or conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders.
    14. Active Hepatitis B infection without antiviral treatment.
    15. Positive test for Hepatitis C ribonucleic acid; Note: Patients in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or those who achieved a sustained virological response after antiviral treatment and show absence of detectable HCV RNA ≥ 6 months or ≥ 12 months after cessation of antiviral treatment are eligible.
    16. Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral load are allowed. In patients with HIV, viral RNA load and CD4+ cell count should be monitored per local standard of care (e.g., every 3 months). HIV testing is not required unless mandated by local health authority or regulations
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 Dose escalation
    Primary endpoint
    1. Incidence and severity of DLTs during Cycle 1.

    Phase 2 Dose expansion
    Primary endpoint
    2. ORR per RECIST v.1.1 based on Investigator assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Cycle 1
    2. Along the study phase 2
    E.5.2Secondary end point(s)
    Phase 1 Dose escalation
    Secondary endpoints
    1. Safety: Incidence, severity and relationship of AEs and SAEs; incidence,
    severity and changes in laboratory values; measures and changes in ECG and vital signs.
    2. Tolerability: Discontinuations due to AEs, dose modifications due to AEs.
    3. Efficacy: BOR, DCR, DoR, PFS and OS, per RECIST v1.1 based on Investigator assessment.
    4. Pharmacokinetics: MCLA-129 concentration CEOI, Cmax, C0h and PK
    parameters including AUC, CL, Vss, tmax and t1/2 and to develop a population PK model.
    5. Immunogenicity: Incidence and serum titers of antidrug antibodies against MCLA-129.
    6. Cytokines: Change from baseline in systemic cytokines.

    Exploratory endpoints
    7. Biomarkers: Change from baseline in biomarkers, and correlative analyses of biomarkers with antitumor response.

    Phase 2 Dose expansion
    Secondary endpoints
    8. Efficacy: BOR, DCR, DoR, PFS, per RECIST v1.1 based on Investigator assessment and OS.
    9. Safety: Incidence, severity and relationship of AEs and SAEs; incidence, severity and changes in laboratory values; measures and changes in ECG and vital signs.
    10. Tolerability: Discontinuations due to AEs, dose modifications due to AEs.
    11. Pharmacokinetics: MCLA-129 concentration CEOI, Cmax, C0h, and PK parameters including AUC, CL, Vss, tmax and t1/2 and to develop a
    population PK model.
    12. Immunogenicity: Incidence and serum titers of antidrug antibodies against MCLA-129.

    Exploratory:
    13. Biomarkers: Change from baseline in biomarkers, and correlative analyses of biomarkers with antitumor response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2.Along phase1
    3.Every 8 wks after start treatment until progression
    4.Cycle 1:Day1,4,8,15,22. Cycle 2:Day1&15. Cycle 3:Day1, then every 4 cycles after Day1
    5.Day1 Cycles1,2,3 then every 4 cycles & EoT visit
    6.Cycle1 only, on Day1 pre-dose, 2,4&22 h post-end of infusion (EOI) and Day15, pre-dose, 2&4 h post-EOI
    7.Cycle1:Pre-dose Day1,EOI,22 h post- EOI; Any time on Days4 or 5 & 8; pre-dose and EOI, Day15; Day22 Cycle2:pre-dose & EOI on Days1&15
    8.Every 8 wks after start treatment until progression
    9,10.Along phase2
    11.Cycles1,2,3 then every 4 cycles
    12.Day1 Cycles 1,2,3 then every 4 cycles
    13.ctDNA:Pre-dose Day 1 Cycle 1. Plasma & Serum PD: Cycle 1: Pre-dose Day 1,EOI,22 h post-EOI; any time on Days 4 or 5,&8; pre-dose & EOI Day 15; Day 22. Cycle 2: pre-dose & EOI on Day 1 & 15
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Singapore
    Belgium
    France
    Germany
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Portugal
    Spain
    Thailand
    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
    The study will be closed after the last patient on study has been followed-up for 12 months or initiates a new anticancer treatment, whichever occurs first.
    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 days0
    E.8.9.2In all countries concerned by the trial years3
    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: 184
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 276
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 460
    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)
    In the event of premature discontinuation of the trial for patients who have proven clinical benefit with MCLA-129, the Sponsor will provide MCLA-129 on a case-by-case basis outside the context of the study. Continued evidence of clinical benefit will need to be provided by the Investigator every 3 months to ensure continued provision of study drug.
    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 Decision2022-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-23
    P. End of Trial
    P.End of Trial StatusOngoing
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