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    Summary
    EudraCT Number:2021-000021-27
    Sponsor's Protocol Code Number:ZN-c3-003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-000021-27
    A.3Full title of the trial
    A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination with Gemcitabine in Adult and Pediatric Subjects with Relapsed or Refractory Osteosarcoma
    Estudio de fase I/II, de Escalada de Dosis y Expansión de Dosis, de ZN-c3 en combinación con gemcitabina en adultos y niños con osteosarcoma recidivo o refractario al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the clinical activity and safety of ZN-c3 in Combination with Gemcitabine in Adult and Pediatric Subjects with Relapsed or Refractory Osteosarcoma
    Estudio para evaluar la actividad clínica y la seguridad de ZN-c3 en combinación con gemcitabina en adultos y niños con osteosarcoma recidivado o resistente al tratamiento
    A.4.1Sponsor's protocol code numberZN-c3-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04833582
    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 SponsorK-Group Beta
    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 supportK-Group Beta, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationK-Group Beta
    B.5.2Functional name of contact pointVP Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address530 7th Avenue, suite 2201
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10018
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 609 619 9909
    B.5.6E-mailmrao@zentalis.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 nameZN-c3
    D.3.2Product code ZN-c3
    D.3.4Pharmaceutical form Film-coated 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 INNNA
    D.3.9.1CAS number Pending
    D.3.9.2Current sponsor codeZN-c3
    D.3.9.3Other descriptive nameZN-c3
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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.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 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 nameZN-c3
    D.3.2Product code ZN-c3
    D.3.4Pharmaceutical form Film-coated 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 INNNA
    D.3.9.1CAS number Pending
    D.3.9.2Current sponsor codeZN-c3
    D.3.9.3Other descriptive nameZN-c3
    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 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.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 Yes
    D.2.1.1.1Trade name Ribozar®
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Farmacêutica S.A. Estrada do Rio da Mó 8, 8A – 8B, Fervença 2705-906 Terrugem SNT , Portugal
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGemcitabine
    D.3.2Product code L01BC05
    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 INNGEMCITABINE
    D.3.9.1CAS number 122111-03-9
    D.3.9.2Current sponsor codeGEMCITABINE
    D.3.9.3Other descriptive nameGEMCITABINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    Relapsed or Refractory Osteosarcoma
    osteosarcoma recidivado o resistente al tratamiento
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Osteosarcoma
    osteosarcoma recidivado o resistente al tratamiento
    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 HLT
    E.1.2Classification code 10039498
    E.1.2Term Bone sarcomas
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1:
    - To investigate the safety and tolerability, including identification of the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ZN-c3 in combination with gemcitabine
    Phase 2:
    - To evaluate the clinical activity of WEE1 inhibition by ZN-c3 in combination with gemcitabine in subjects with relapsed/refractory osteosarcoma as assessed by the event-free survival (EFS) at 18 weeks, per response evaluation criteria in solid tumors RECIST Guideline version 1.1
    Fase I:
    • Investigar la seguridad y la tolerabilidad, incluida la identificación de la dosis máxima tolerada (DMT) y la dosis recomendada para la fase 2 (DRF2) de ZN-c3 en combinación con gemcitabina.

    Fase II:
    • Evaluar la actividad clínica de la inhibición de WEE1 por la acción de ZN-c3 en combinación con gemcitabina en sujetos con osteosarcoma recidivado/resistente al tratamiento, según la evaluación de la supervivencia libre de acontecimientos (SLSA) a las 18 semanas, según los criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1.
    E.2.2Secondary objectives of the trial
    - To further evaluate the clinical activity based on EFS according to RECIST Guideline version 1.1 and to determine median overall survival (OS) and OS at 12 months of ZN-c3 in combination with gemcitabine
    - To further investigate the safety and tolerability of ZN-c3 in combination with gemcitabine
    - To investigate the plasma pharmacokinetics (PK) of ZN-c3 (and its potential metabolites as applicable) when given in combination with gemcitabine
    • Evaluar en mayor profundidad la actividad clínica basada en la SLA de acuerdo con la versión 1.1 de los criterios RECIST y determinar la mediana de la supervivencia global (SG) y la SG a los 12 meses de ZN-c3 en combinación con gemcitabina.
    • Seguir investigando la seguridad y tolerabilidad de ZN-c3 en combinación con gemcitabina
    • Investigar la farmacocinética (FC) plasmática de ZN-c3 (y sus posibles metabolitos, según proceda) cuando se administra en combinación con gemcitabina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥12 years old at the time of informed consent.
    2. Body weight ≥40 kg.
    3. Histologically documented relapsed or metastatic osteosarcoma, as confirmed at the local study site.
    a) The disease must have failed standard therapy and there is no known curative therapy available, or any available standard of care therapy was not tolerated or was refused by the subject.
    b) The Investigator must confirm that gemcitabine is an appropriate treatment approach.
    c) Subjects may have had any number of prior therapies and prior treatment with gemcitabine is allowed.
    4. Must have measurable disease according to RECIST Guideline version 1.1 criteria.
    5. Adequate hematologic and organ function.
    6. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception prior to the first dose and for 6 months after the last dose of ZN-c3 and/or gemcitabine.
    7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    1. Edad ≥ 12 años en el momento del consentimiento informado.
    2. Peso corporal ≥ 40 kg.
    3. Osteosarcoma recidivado o metastásico documentado histológicamente, según lo confirmado en el centro del estudio local.
    a) Debe haber fracasado el tratamiento de referencia contra la enfermedad y no existe ningún tratamiento curativo conocido, o todos los tratamientos de referencia disponibles no fueron tolerados o fueron rechazados por el sujeto.
    b) El investigador debe confirmar que el tratamiento con gemcitabina es una estrategia terapéutica adecuada.
    c) Los pacientes pueden haber recibido cualquier número de tratamientos previos y se permite el tratamiento previo con gemcitabina.
    4. Deben presentar enfermedad mensurable de acuerdo con los criterios RECIST versión 1.1.
    5. Función hematológica y orgánica adecuada.
    6. Las mujeres con capacidad de procrear en edad fértil y los varones deben aceptar usar un método anticonceptivo eficaz según las normas institucionales antes de la primera dosis y durante 6 meses después de la última dosis de ZN-c3 y gemcitabina.
    7. Estar dispuestos y ser capaces de cumplir las visitas programadas, el plan de tratamiento, las pruebas analíticas y demás procedimientos del estudio.
    E.4Principal exclusion criteria
    1. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
    2. Prior therapy with a WEE1 inhibitor.
    3. A serious illness or medical condition(s).
    4. Pregnant or lactating females (including the cessation of lactation) or females of childbearing potential who have a positive serum pregnancy test within 14 days prior to Cycle 1 Day 1.
    5. Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
    6. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
    7. History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
    8. Taking medications with a known risk of TdP.
    9. Administration of strong and moderate CYP3A4 inhibitors and inducers and P-gp inhibitors.
    1. Toxicidad no resuelta de grado > 1 atribuida a cualquier tratamiento previo (excepto neuropatía, alopecia o pigmentación cutánea de grado ≤ 2).
    2. Tratamiento previo con un inhibidor de WEE1.
    3. Enfermedad(es) o patología(s) grave(s).
    4. Mujeres embarazadas o en periodo de lactancia (incluida la interrupción de la lactancia) o mujeres con capacidad de procrear en edad fértil que tengan un resultado positivo en una prueba de embarazo en suero en los 14 días previos al D1C1.
    5. Sujetos con una segunda neoplasia maligna activa (no controlada, metastásica) o que requieren tratamiento.
    6. ECG de 12 derivaciones con un intervalo QT corregido mediante la fórmula de Fridericia (QTcF) > 470 ms, excepto en los sujetos con marcapasos auriculoventriculares u otros trastornos (p. ej., bloqueo de rama derecha) que invaliden que la medición del intervalo QT no sea válida.
    7. Antecedentes, signos actuales o antecedentes familiares de síndrome de QT largo congénito o torsades de pointes (TdP).
    8. Tomar medicamentos con riesgo conocido de provocar TdP.
    9. Administración de inhibidores e inductores potentes y moderados de la isoenzima CYP3A4 e inhibidores de la gp-P
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1 of Phase 1
    2. EFS at 18 weeks (Phase 2)
    • Incidencia e intensidad de las toxicidades limitantes de la dosis (TLD) en los pacientes en los que son evaluables las TLD durante el ciclo 1 de la fase 1
    • SLSA a las 18 semanas (fase 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Cannot be predicted as this study is to assess those parameters
    2. Percentage cannot be predicted as this study is to assess this - the study will follow the Guideline for Osteosarcoma
    1. No se puede predecir ya que este estudio es para evaluar esos parámetros.
    2. El porcentaje no se puede predecir ya que este estudio es para evaluar esto; el estudio seguirá las Directrices para el osteosarcoma
    E.5.2Secondary end point(s)
    1. Clinical activity:
    According to RECIST Guideline version1.1 and clinical criteria:
    - ΕFS
    - OS (median and at 12 months)
    2. Incidence and severity of adverse events (AEs) graded according to NCI common terminology criteria for adverse events (CTCAE), version 5.0
    3. Plasma PK parameters of ZN-c3 (and its potential metabolites as applicable), including but not limited to maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve over the dosing interval
    1. Actividad clínica:
    De acuerdo con los criterios RECIST en su versión 1.1 y los criterios clínicos:
    - SSLA
    - SG (mediana y a los 12 meses)
    2. Incidencia e intensidad de los acontecimientos adversos (AA) clasificados según los criterios terminológicos comunes para acontecimientos adversos (CTCAE) del NCI, versión 5.0
    3. Parámetros FC plasmáticos de ZN-c3 (y sus posibles metabolitos, según el caso), incluidos, entre otros, la concentración máxima (Cmáx), el tiempo que tarda en alcanzarse la concentración máxima (Tmáx) y el área bajo la curva de concentración-tiempo durante el intervalo de administración
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Tumor imaging assess conducted prior to informed consent may be used for screening if they are collected within 28 days prior to Cycle 1 Day 1. Subsequent tumor imaging assess will be performed every 6 weeks (42 days) ± 4 days from Cycle 1 Day 1, and at the time of discontinuation.
    2. Review on an ongoing basis.
    3. Abbreviated ZN-c3 PK Sampling Time Points Day: Cycle 1 Day 15; 2 hours (± 10 min) post ZN-c3 admin; 4 hours (± 1 hour) post ZN-c3 admin; Cycles 2-6 Day 1. Collection Time Points : Pre-dose (within 0.5 hour prior to ZN-c3 admin) - Cycles 2-6 Day 1.
    1. La evaluación de las imágenes del tumor realizada antes del consentimiento informado puede utilizarse para la detección si se recogen dentro de los 28 días anteriores al Día 1 del Ciclo 1. La evaluación posterior de las imágenes del tumor se realizará cada 6 semanas (42 días) ± 4 días desde el Día 1 del Ciclo 1, y en el momento de la interrupción.
    2. Revise de forma continua.
    3. Puntos de tiempo de muestra de PK ZN-c3 abreviado Día: Ciclo 1 Día 15; 2 horas (± 10 min) después de la administración de ZN-c3; 4 horas (± 1 hora) después de la administración de ZN-c3; Ciclos 2-6 Día 1. Puntos de tiempo de recolección: Predosis (dentro de 0.5 horas antes de la administración de ZN-c3) - Ciclos 2-6 Día 1.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    dose escalation and dose expansion
    Escalada de dosis y expansión de dosis
    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
    To investigate the safety and tolerability, including identification of the maximum tolerated dose
    Investigar la seguridad y la tolerabilidad, incluida la identificación de la dosis máxima tolerada
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    France
    Germany
    Netherlands
    Spain
    Ukraine
    United Kingdom
    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
    Ultima visita del ultimo paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 26
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 26
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors will be enrolled in the study. Persons in this age group are not generally capable of consenting. Parents consent will be given for them.
    En el estudio participarán menores de edad. Las personas de este grupo de edad no suelen ser capaces de dar su consentimiento. Se dará el consentimiento de los padres por ellos.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 84
    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)
    If there is strong evidence of clinical benefit and reasons to justify continuation of the study drug, even though treatment discontinuation criteria have been met, this decision must be reviewed with the Sponsor, and continuation of therapy may be allowed assuming all other treatment resumption criteria have been met.
    Si hay pruebas sólidas de beneficio clínico y razones para justificar la continuación del estudio sobre el fármaco, aunque se hayan cumplido los criterios de interrupción del tratamiento, esta decisión debe revisarse con el Promotor y se puede permitir la continuación de la terapia asumiendo que se han cumplido todos los demás criterios de reanudación del tratamiento.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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