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    Summary
    EudraCT Number:2020-005492-12
    Sponsor's Protocol Code Number:BDTX-189-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-22
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-005492-12
    A.3Full title of the trial
    MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients with Advanced Solid Malignancies
    MasterKey-01: Estudio de fase 1/2, multicéntrico, abierto y de dos partes, para evaluar la seguridad, tolerabilidad, farmacocinética y actividad antitumoral de BDTX-189, un inhibidor de mutaciones alostéricas de ErbB, en pacientes con neoplasias malignas sólidas avanzadas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1/2 Study to Assess the Safety and Antitumor Activity of BDTX-189 in Patients with Advanced Solid Malignancies
    Estudio de fase 1/2, multicéntrico para evaluar la seguridad y actividad antitumoral de BDTX-189 en pacientes con neoplasias malignas sólidas avanzadas
    A.3.2Name or abbreviated title of the trial where available
    MasterKey-01
    A.4.1Sponsor's protocol code numberBDTX-189-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04209465
    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 SponsorBlack Diamond Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportBlack Diamond Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIVOTAL S.L.U.
    B.5.2Functional name of contact pointMedical Departament
    B.5.3 Address:
    B.5.3.1Street AddressC/ Gobelas, 19
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917081250
    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 nameBDTX-189
    D.3.2Product code BDTX-189
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBDTX-189
    D.3.9.3Other descriptive nameBDTX-189
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lung cancer, breast cancer, any other solid tumors with specific gene mutations
    Cáncer de pulmón, Cáncer de mama y cualquier otro tumor sólido con mutaciones específicas
    E.1.1.1Medical condition in easily understood language
    Lung cancer, breast cancer, any other solid tumors with specific gene mutations
    Cáncer de pulmón, Cáncer de mama y cualquier otro tumor sólido con mutaciones específicas
    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 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the antitumor activity of BDTX-189 as a single agent by evaluation of objective response as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in patients with allosteric human epidermal growth factor receptor 2 (HER2) mutations, including epidermal growth factor receptor(EGFR)/HER2 exon 20 insertion mutations
    Evaluar la actividad antitumoral de BDTX-189 en monoterapia mediante la evaluación de la respuesta objetiva, determinada según los Criterios de evaluación de respuesta en tumores sólidos (Response Evaluation Criteria in Solid Tumors, RECIST) v1.1, en pacientes con mutaciones alostéricas del receptor 2 del factor de crecimiento epidérmico humano (HER2), incluidas mutaciones de inserción del exón 20 del receptor factor de crecimiento epidérmico (EGFR)/HER2
    E.2.2Secondary objectives of the trial
    - Assess the safety and tolerability of BDTX-189 as an oral single agent
    - Investigate the PK of BDTX-189 using population PK (PopPK) methods and explore correlations between PK, response, and/or safety findings
    - Assess additional measures of antitumor activity of BDTX-189 as a single agent by evaluation of DOR, disease control and PFS as determined by RECIST v1.1, and overall survival (OS)
    - Evaluar la seguridad y la tolerabilidad de BDTX-189 por vía oral en monoterapia
    - Investigar la farmacocinética (pharmacokinetics, PK) de BDTX-189 con métodos de PK poblacional (PopPK) y explorar las correlaciones entre PK, respuesta y/o hallazgos de seguridad
    - Evaluar otras medidas de la actividad antitumoral de BDTX 189 en monoterapia, mediante la evaluación de la DOR, el control de la enfermedad y la PFS según RECIST v1.1, así como la supervivencia global (overall survival, OS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically- or cytologically-confirmed locally advanced or metastatic solid tumor with documented recurrence or disease progression from standard anticancer therapy in the advanced/metastatic setting;
    No standard therapy available or standard therapy is considered unsuitable or intolerable according to the Investigator and consultation with the Medical Monitor;
    Patients with a solid tumor harboring an:
    a. Allosteric HER2 mutation
    b. EGFR or HER2 exon 20 insertion mutation
    as determined by a validated next-generation sequencing (NGS) test routinely used by each institution using tissue and/or plasma. Eligible mutations are summarized in Appendix I.
    Eligible patients will be assigned to one of the 4 following cohorts:
    Cohort 1: NSCLC with EGFR or HER2 exon 20 insertion mutation
    Cohort 2: Breast cancer with an allosteric HER2 mutation and EGFR/HER2 exon 20 insertion mutations
    Cohort 3: Any tumor (except breast) with an S310F/Y mutation
    Cohort 4: Any other allosteric HER2 mutation and EGFR/HER2 exon 20 insertion mutations not assigned to Cohorts 1-3;
    Adequate archival tumor tissue or willing to undergo pretreatment biopsy;
    Measurable disease according to RECIST version 1.1.
    -Tumor sólido localmente avanzado o metastásico, confirmado histológica o citológicamente, en recidiva o progresión de la enfermedad documentada tras el tratamiento antineoplásico de referencia para enfermedad avanzada/metastásica
    -No se dispone de un tratamiento de referencia o este se considera inadecuado o no tolerable, en opinión del Investigador y tras consulta con el Monitor Médico
    -Pacientes con tumores sólidos portadores de:
    a.Mutación alostérica de HER2
    b.Mutación de inserción del exón 20 de EGFR o HER2
    en su determinación mediante una prueba validada de secuenciación de nueva generación (next-generation sequencing, NGS) que emplee habitualmente cada centro con tejido y/o plasma. Las mutaciones elegibles se resumen en el Apéndice I. Los pacientes elegibles serán asignados a una de las 4 cohortes siguientes:
    Cohorte 1: cáncer de pulmón no microcítico con mutación de inserción del exón 20 de EGFR o HER2
    Cohorte 2: cáncer de mama con una mutación alostérica de HER2 y mutaciones de inserción del exón 20 de EGFR/HER2
    Cohorte 3: cualquier tumor (excepto de mama) con mutación S310F/Y
    Cohorte 4: cualquier otra mutación alostérica de HER2 y mutaciones de inserción del exón 20 de EGFR/HER2 no asignadas a las cohortes 1-3
    -Tejido tumoral de archivo adecuado o en disposición a someterse a una biopsia antes del tratamiento
    -Enfermedad medible según RECIST versión 1.1
    E.4Principal exclusion criteria
    Clinical laboratory values meeting the following criteria within 4 weeks (28 days) prior to baseline:
    a.Serum creatinine ≥1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≤60 mL/min using Cockcroft-Gault equation
    b.Total bilirubin ≥1.5 × ULN or ≥3.0 × ULN in the presence of documented Gilbert’s syndrome
    c.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 × ULN, or AST or ALT ≥5.0 × ULN in the presence of liver metastases
    d. Hematologic function:
    i. Absolute neutrophil count (ANC) ≤1000 cells/μL
    ii. Hemoglobin ≤8.5 g/dL or 5.28 mmol/L
    iii. Platelet count ≤75,000/μL
    Significant cardiovascular disease, including:
    a. Cardiac failure New York Heart Association Class III or IV, or left ventricular ejection fraction (LVEF) <50% or below the lower limit of the Institution’s normal range
    b. Myocardial infarction, severe or unstable angina within 6 months prior to baseline
    c. Significant thrombotic or embolic events within 3 months prior to baseline, including, but not limited to, stroke or transient ischemic attack. Catheter-related thrombosis and deep vein thrombosis are not a cause for exclusion
    d. History or presence of any uncontrolled cardiovascular disease
    e. Personal or family history of long QT syndrome
    Electrocardiogram (ECG) findings obtained using the study site’s ECG machine-derived measurements, meeting any of the following criteria:
    a. Evidence of second- or third-degree atrioventricular block
    b. Clinically significant arrhythmia (as determined by the Investigator)
    c. QTc interval of >470 msec as calculated according to Fridericia’s formula (QTcF = QT/R to R interval0.33)
    Leptomeningeal or untreated and/or symptomatic central nervous system (CNS) malignancies (primary or metastatic); patients with asymptomatic CNS metastases who have undergone surgery or radiotherapy and who have been on a stable or tapering dose of corticosteroids for at least 2 weeks prior to the first scheduled day of dosing will be eligible for the trial
    Women who are pregnant or breast-feeding
    Taking or unable to discontinue proton pump inhibitors within 1 week prior to baseline
    Known concurrent KRAS mutation
    Known tumor-harboring resistance mutations including EGFR T790M or C797S mutations or HER2 C805S mutation
    Prior documented treatment response (i.e., complete response [CR], partial response [PR], or stable disease [SD] lasting ≥24 weeks by RECIST v1.1) to approved or investigational HER2 or EGFR therapies (e.g., afatinib, lapatinib, dacomitinib,
    neratinib, trastuzumab deruxtecan, poziotinib, mobocertinib, amivantamab)
    a. Patients with or without tumor response discontinuing after 8 weeks or less of therapy due to toxicity may be considered after discussion with the Sponsor Medical Monitor
    -Valores de laboratorio que cumplan los siguientes criterios en el plazo de las 4 semanas (28 días) anteriores al momento basal:
    a.Creatinina sérica mayor o igual a 1,5 × límite superior de la normalidad (ULN) o aclaramiento de creatinina calculado ≤60 ml/min mediante la ecuación de Cockcroft-Gault
    b.Bilirrubina total mayor o igual a 1,5 × ULN o mayor o igual a ,30 × ULN en caso de síndrome de Gilbert documentado
    c.Aspartato-aminotransferasa (AST) o alanina-aminotransferasa (ALT) mayor o igual a 2,5 × ULN, o AST o ALT mayor o igual a 5,0 × ULN en presencia de metástasis hepáticas
    d.Función hematológica:
    i.Cifra absoluta de neutrófilos ( ANC) menor o igual a 1000 células/μl
    ii.Hemoglobina menor o igual a 8,5 g/dl o 5,28 mmol/l
    iii.Cifra de plaquetas menor o igual a 75,000/μl
    -Enfermedad cardiovascular importante, como:
    a.Insuficiencia cardiaca de clase III o IV de la New York Heart Association, o fracción de eyección del ventrículo izquierdo ( LVEF) menor de 50% o por debajo del límite inferior del rango normal del centro
    b.Infarto de miocardio, angina severa o inestable en los 6 meses anteriores al momento basal
    c.Episodios trombóticos o embólicos importantes en el plazo de los 3 meses anteriores al momento basal, tales como, entre otros, accidente cerebrovascular o accidente isquémico transitorio. La trombosis asociada al catéter y la trombosis venosa profunda no son motivo de exclusión
    d.Antecedentes o presencia de enfermedad cardiovascular no controlada
    e.Antecedentes personales o familiares de síndrome del QT largo
    -Hallazgos del electrocardiograma (ECG), según las mediciones del electrocardiógrafo del centro del estudio, que cumplan cualquiera de los siguientes criterios:
    a.Signos de bloqueo auriculoventricular de segundo o tercer grado
    b.Arritmia de importancia clínica (a juicio del Investigador)
    c.Intervalo QTc mayor de 470 ms calculado con la fórmula de Fridericia (QTcF = QT/intervalo RR0,33)
    -Neoplasias malignas leptomeníngeas o del sistema nervioso central (central nervous system, CNS) no tratadas y/o sintomáticas (primarias o metastásicas); podrán entrar en el estudio los pacientes con metástasis asintomáticas en el sistema nervioso central que se hayan sometido a cirugía o radioterapia y que hayan recibido una dosis estable o decreciente de corticosteroides durante al menos 2 semanas antes del primer día programado de tratamiento
    -Mujeres embarazadas o en periodo de lactancia
    -En tratamiento con inhibidores de la bomba de protones, o que no puedan suspenderlos, en el plazo de la semana anterior al momento basal
    -Mutación de KRAS concomitante conocida
    -Tumores portadores de mutaciones de resistencia conocidas, tales como mutaciones T790M o C797S de EGFR o mutación C805S de HER2
    -Respuesta documentada (eso es, respuesta completa [complete response, CR], respuesta parcial [PR] o enfermedad estable [SD] de ≥24 semanas de duración según RECIST v1.1) a un tratamiento previo, aprobado o en investigación, frente a HER2 o EGFR (por ejemplo, afatinib, lapatinib, dacomitinib, neratinib, trastuzumab deruxtecán, poziotinib, mobocertinib, amivantamab)
    a.Se podrá considerar la participación en el estudio de los pacientes con o sin respuesta tumoral que suspendan el tratamiento por toxicidad al cabo de 8 semanas o menos, previa discusión con el Monitor Médico del Promotor
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed objective response rate (ORR) defined as either a complete response (CR) or partial response (PR) by RECIST version 1.1 as determined by the Investigator based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
    Tasa de respuesta objetiva confirmada (ORR) definida como una respuesta completa (CR) o una respuesta parcial (PR) por RECIST versión 1.1 según lo determinado por el investigador basado en tomografía computarizada (TC) o imágenes por resonancia magnética (MRI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated for response to treatment after 2 cycles of treatment. Response will be assessed at 6-week intervals (±3 days) during the first 24 weeks (8 cycles) of study treatment. Thereafter, patients will be evaluated for response to treatment every 12 weeks (±7 days), at the EOT visit (if not performed within the previous 4 weeks), and at the discretion of the Investigator.
    Se evaluará la respuesta de los pacientes al tratamiento después de 2 ciclos de tratamiento. La respuesta se evaluará a intervalos de 6 semanas (mas/menos 3 días) durante las primeras 24 semanas (8 ciclos) del tratamiento del estudio. A partir de entonces, se evaluará la respuesta de los pacientes al tratamiento cada 12 semanas (mas/menos 7 días), en la visita de EOT (si no se realizó dentro de las 4 semanas previas) y a discreción del investigador.
    E.5.2Secondary end point(s)
    Incidence of TEAEs; changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters, cardiac function; and physical examination results PopPK parameters oral clearance (Cl/F), oral volume of distribution (Vd/F), and first-order absorption rate constant (Ka) for BDTX-189. Cl/F will be used to generate estimates of BDTX-189 area under the concentration time curve (AUC). Possible PK/safety, PK/efficacy correlations, and covariate analysis of intrinsic/extrinsic factors. Additional measures of antitumor activity including
    DOR, DCR, PFS, and OS.
    Incidencia de TEAE (efecto adversos tratamiento-emergente) ; cambios en los parámetros de laboratorio clínico, signos vitales y parámetros del electrocardiograma (ECG), función cardíaca; y resultados del examen físico. Parámetros de PopPK, aclaramiento oral (Cl / F), volumen de distribución oral (Vd / F) y constante de velocidad de absorción de primer orden (Ka) para BDTX-189. Cl / F se utilizará para generar estimaciones del área de BDTX-189 bajo la curva de concentración-tiempo (AUC). Posibles correlaciones PK / seguridad, PK / eficacia y análisis de covariables de factores intrínsecos / extrínsecos. Medidas adicionales de actividad antitumoral que incluyen DOR, DCR, PFS y OS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated for response to treatment after 2 cycles of treatment. Response will be assessed at 6-week intervals (±3 days) during the first 24 weeks (8 cycles) of study treatment. Thereafter, patients will be evaluated for response to treatment every 12 weeks (±7 days), at the EOT visit (if not performed within the previous 4 weeks), and at the discretion of the Investigator. Other endpooints will be evaluated at the end of the trial.
    Se evaluará la respuesta de los pacientes al tratamiento después de 2 ciclos de tratamiento. La respuesta se evaluará a intervalos de 6 semanas (mas/menos 3 días) durante las primeras 24 semanas (8 ciclos) del tratamiento del estudio. A partir de entonces, se evaluará la respuesta de los pacientes al tratamiento cada 12 semanas (mas/menos 7 días), en la visita de EOT (si no se realizó dentro de las 4 semanas previas) y a discreción del investigador.
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety Expansion portion
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    Canada
    Israel
    United States
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    United Kingdom
    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 years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 80
    F.4.2.2In the whole clinical trial 100
    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 Decision2021-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-02
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