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    Summary
    EudraCT Number:2017-001111-36
    Sponsor's Protocol Code Number:CAN04CLIN001
    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:2019-10-21
    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 number2017-001111-36
    A.3Full title of the trial
    An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors
    Ensayo abierto, de escalado seguido por expansión de dosis, de seguridad y de tolerabilidad de CAN04, un anticuerpo monoclonal completamente humanizado contra IL1RAP, en sujetos con tumores malignos sólidos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A dose escalation trial to assess the safety and tolerability of multiple doses of the CAN04 antibody, in patients with solid malignant tumors.
    Ensayo de escalado de dosis para evaluar la seguridad y tolerabilidad de múltiples dosis del anticuerpo CAN04 en sujetos con tumores malignos sólidos.
    A.3.2Name or abbreviated title of the trial where available
    CANFOUR
    A.4.1Sponsor's protocol code numberCAN04CLIN001
    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 SponsorCantargia AB
    B.1.3.4CountrySweden
    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 supportCantargia AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressWalaardt Sacréstraat 401-403
    B.5.3.2Town/ citySchiphol
    B.5.3.3Post code1117 BM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31204350 580
    B.5.5Fax number31204350 589
    B.5.6E-mailregulatory@sms-oncology.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 nameCAN04
    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 INNFULLY HUMANIZED LOW FUCOSE IGG1Κ MONOCLONAL ANTIBODY TARGETING IL1RAP
    D.3.9.2Current sponsor codeCAN04
    D.3.9.4EV Substance CodeSUB187322
    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 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
    Solid malignant tumors, in the following two indications;
    Non-Small Cell Lung Cancer (NSCLC) and
    Pancreatic Ductal Adenocarcinoma (PDAC),
    Tumores malignos sólidos, en las siguientes dos indicaciones;
    Cáncer pulmonar de células no pequeñas (CPCNP) y
    Adenocarcinoma ductal de páncreas (ADP)
    E.1.1.1Medical condition in easily understood language
    Solid malignant tumors, in the following two indications;
    Non-Small Cell Lung Cancer (NSCLC) and
    Pancreatic Ductal Adenocarcinoma (PDAC)
    Tumores malignos sólidos, en las siguientes dos indicaciones;
    Cáncer pulmonar de células no pequeñas (CPCNP) y
    Adenocarcinoma ductal de páncreas (ADP)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073364
    E.1.2Term Ductal adenocarcinoma of pancreas
    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
    Part I
    • To define the Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) of CAN04 once weekly (Q1W) in subjects with relapsed or refractory NSCLC, PDAC, TNBC or CRC.
    Part II
    • To determine the safety and tolerability of CAN04 in subjects with NSCLC or PDAC tumors, when given as monotherapy or in combination with standard chemotherapy regimen.
    Parte I
    • Definir la dosis máxima tolerada (MTD) o la dosis recomendada de fase 2 (RP2D) de CAN04, dadas una vez por semana (Q1W) en sujetos con NSCLC, PDAC, TNBC o CRC recurrentes o refractarios.
    Parte II
    • Determinar la seguridad y la tolerabilidad de CAN04 en sujetos con tumores NSCLC o PDAC, cuando se administran en monoterapia o en combinación con un régimen de quimioterapia estándar.
    E.2.2Secondary objectives of the trial
    • To assess pharmacokinetic (PK) parameters of CAN04.
    • To assess anti-drug antibody (ADA) formation against CAN04.
    • To determine preliminary signs of clinical efficacy of CAN04 as a single agent.
    Additional secondary objectives for Part II
    • To assess health-related quality of life.
    • To determine preliminary signs of clinical efficacy of CAN04 when given in combination with standard chemotherapy regimen
    • Evaluar los parámetros farmacocinéticos (PK) de CAN04.
    • Evaluar la formación de anticuerpos antimedicamentos (ADA) contra CAN04.
    • Determinar signos preliminares de eficacia clínica de CAN04 como agente único.
    Objetivos secundarios adicionales para la Parte II
    • Evaluar la calidad de vida (QoL) relacionada con la salud.
    • Determinar signos preliminares de eficacia clínica de CAN04 cuando se administra en combinación con un régimen estándar de quimioterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand and willingness to provide written informed consent before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
    2. Age ≥ 18 year.
    3. Measurable disease in accordance to irRC by computed tomography (CT) or magnetic resonance imaging (MRI) scan, no more than 6 weeks prior to screening.
    4. At least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies.
    5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
    6. Adequate bone marrow, hepatic, renal and coagulation function.
    7. Clinical laboratory values at screening:
     Serum creatinine <1.5xULN
     Hemoglobin >9.0 g/dL
     Absolute neutrophil count >1000/μL in Part I and >1500/μL in Part II
     Platelets >75x109/L
     Total bilirubin <1.5x ULN
     Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤3x ULN (for subjects with hepatic metastases <5x ULN)
     Prothrombin Time (PT) & Partial Thromboplastin Time (PTT) within 1.5x institutional ULN. In case there are no normal ranges available for the PT test, the international normalized ratio (INR) test may be used instead of PT. At screening, subjects should have an INR <1.5x ULN.
    Additional inclusion criterion for Part I
    8. Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic NSCLC, PDAC, CRC or TNBC tumor, relapsed or refractory to standard therapy or for which there is no standard therapy.
    Additional inclusion criterion for Part II:
    9. Arm A, Arm B and Arm E: Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic squamous or non-squamous NSCLC or PDAC, relapsed or refractory to standard of care therapy or for whom there is no standard therapy.
    10. All arms: Presence of tumor lesions amenable to biopsy and willingness to undergo repeat biopsies of these tumor lesions.
    11. Arm C only:
    11a: Subjects with histologically or cytologically confirmed diagnosis of unresectable stage IIIB or stage IV squamous or non-squamous NSCLC
    11b: Subjects must be eligible to receive a first line standard chemotherapy regimen with cisplatin/gemcitabine or a second line standard chemotherapy regimen with cisplatin/gemcitabine after relapsing from first line with pembrolizumab monotherapy.
    11c: Subjects who underwent (neo)adjuvant treatments are eligible if the (neo)adjuvant treatment ended at least 6 months prior to inclusion.
    12. Arm D only:
    12a: Subjects with newly diagnosed, treatment naїve, histologically or cytologically confirmed, unresectable, locally advanced or metastatic (stage III or stage IV) PDAC.
    12b: Subjects must be eligible to receive treatment with nabpaclitaxel and gemcitabine.
    12c: Subjects who underwent (neo)adjuvant treatments are eligible if the (neo)adjuvant treatment ended at least 6 months prior to inclusion.
    1. Capacidad para entender y disposición para dar un consentimiento informado por escrito antes de cualquier actividad relacionada con el estudio. (Las actividades relacionadas con el estudio son procedimientos que no se habrían realizado durante el manejo normal del sujeto).
    2. Edad ≥ 18 años.
    3. Enfermedad medible de acuerdo con los irRC por tomografía computarizada (CT) o imágenes por resonancia magnética (MRI), no más de 6 semanas antes de la selección.
    4. Al menos 4 semanas desde la última dosis de quimioterapia, radioterapia, inmunoterapia o cirugía; al menos 6 semanas para terapia que se sabe que tiene toxicidad retrasada; al menos 4 semanas desde el tratamiento con terapias biológicas/dirigidas.
    5. Estado de rendimiento ≤ 1 del Eastern Cooperative Oncology Group (ECOG).
    6. Función adecuada de médula ósea, hepática, renal y de coagulación.
    7. Valores de laboratorio clínico durante la selección:
     Creatinina sérica < 1.5 x ULN (límite máximo normal)
     Hemoglobina > 9.0 g/dl
     Recuento absoluto de neutrófilos > 1000/μl en la Parte I y > 1500/μl en la Parte II
     Plaquetas > 75 x 109/l
     Bilirrubina total < 1.5 x ULN
     Aspartato transaminasa (AST) y alanina transaminasa (ALT) ≤ 3 x ULN (para sujetos con metástasis hepáticas < 5 x ULN)
     Tiempo de protrombina (PT) y tiempo parcial de tromboplastina (PTT) dentro de 1.5 x ULN institucional. En caso de que no haya rangos normales disponibles para la prueba de PT, se puede usar la prueba de la relación normalizada internacional (INR) en lugar del PT. En la selección, los sujetos deben tener una INR <1.5 x ULN.
    Criterio de inclusión adicional para la Parte I
    8. Sujetos con tumor de NSCLC, PDAC, CRC o TNBC confirmado histológicamente o citológicamente, no resecable, localmente avanzado o metastásico, recidivante o resistente al tratamiento estándar o para el que no existe un tratamiento estándar.
    Criterio de inclusión adicional para la Parte II:
    9. Brazos A, B y E: Sujetos con NSCLC escamoso o no escamoso, o PDAC confirmados histológicamente o citológicamente, no resecables, localmente avanzados o metastásicos, recidivantes o refractarios a la terapia de atención estándar o para quienes no existe una terapia estándar.
    10. Todos los brazos: Presencia de lesiones tumorales susceptibles de biopsia y disposición para someterse a biopsias repetidas de estas lesiones tumorales.
    11. Solo brazo C:
    11a: Sujetos con diagnóstico confirmado histológicamente o citológicamente de NSCLC escamoso o no escamoso en etapa IIIB o etapa IV no resecable
    11b: Los sujetos deben ser elegibles para recibir un régimen de quimioterapia estándar de primera línea con cisplatino/gemcitabina o un régimen de quimioterapia estándar de segunda línea con cisplatino/gemcitabina después de recaer desde la primera línea con monoterapia con pembrolizumab.
    11c: Los sujetos que se sometieron a tratamientos (neo)adyuvantes son elegibles si el tratamiento (neo)adyuvante finalizó al menos 6 meses antes de la inclusión.
    12. Solo brazo D:
    12a: Sujetos con PDAC (etapa III o etapa IV) de diagnóstico reciente, que no ha recibido tratamiento, confirmado histológicamente o citológicamente, no resecable, localmente avanzado o metastásico.
    12b: Los sujetos deben ser elegibles para recibir tratamiento con nab-paclitaxel y gemcitabina.
    12c: Los sujetos que se sometieron a tratamientos (neo)adyuvantes son elegibles si el tratamiento (neo)adyuvante finalizó al menos 6 meses antes de la inclusión.
    E.4Principal exclusion criteria
    1. Known or suspected allergy to trial product or related product.
    2. Subjects receiving live vaccination, etanercept or other TNF-α inhibitors
    or any other investigational agents during or just prior to (within 28 days
    of first study drug administration) participation in this study.
    3. Previous participation in this trial (enrolled).
    4. Clinical evidence of an active second malignancy.
    5. Subjects with a life expectancy <12 weeks.
    6. Uncontrolled or significant cardiovascular disease defined as New York Heart Association Classification III, or IV.
    7. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
    8. Not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1, with the exception of alopecia grade 2.
    9. Symptomatic brain metastases, which are either untreated or uncontrolled by surgery and/or radiotherapy.
    10. Immunocompromised subject currently receiving systemic therapy.
    11. Subjects with history of HIV, hepatitis B or C exposure currently controlled by antiviral therapy.
    12. Known bleeding disorder or coagulopathy.
    13. Subjects with microbial or viral infection, which is not controlled by appropriate medication. Subjects with any type of chronic infection.
    14. Women who are pregnant or breastfeeding.
    15. Women of childbearing potential (WOCBP, defined as < 2 years after last menstruation and not surgically sterile) or men whose sexual partners are WOCBP who are unwilling or unable to use a highly effective method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3-6 months after the last dose of study medication, depending on the treatment arm. Also see section 6.1.10.1 – Contraception Methods
    16. Evidence of serious uncontrolled medical disorder or active infection that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol.
    17. Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion.
    18. Only for Arm C:
    18a Prior lines of treatment with anti-cancer medication other than pembrolizumab monotherapy administered as 1st line.
    18b Known tumor EGFR mutation, unless contraindication to EGFRdirected therapy.
    18c Known tumor ALK rearrangements, unless contraindication to ALKdirected therapy or ALK-directed therapy not available.
    1. Alergia conocida o sospechada al producto de estudio o producto relacionado.
    2. Los sujetos que reciben vacunas vivas, etanercept u otros inhibidores de TNF-α o cualquier otro agente en investigación durante o justo antes de participar en este estudio (dentro de los 28 días de la administración del medicamento del primer estudio).
    3. Participación previa en este estudio (inscrito).
    4. Evidencia clínica de una segunda neoplasia maligna activa.
    5. Sujetos con una esperanza de vida < 12 semanas.
    6. Enfermedad cardiovascular no controlada o significativa definida con la Clasificación III o IV de la New York Heart Association.
    7. Demencia o estado mental alterado que prohibiría la comprensión o la prestación del consentimiento informado.
    8. No se recuperó de los efectos adversos de la terapia previa en el momento de la inscripción a ≤ grado 1, con la excepción de la alopecia grado 2.
    9. Metástasis cerebrales sintomáticas, que no se tratan o no se controlan mediante cirugía o radioterapia.
    10. Sujeto inmunocomprometido que actualmente recibe terapia sistémica.
    11. Sujetos con antecedentes de exposición al VIH, hepatitis B o C actualmente controlados por terapia antiviral.
    12. Trastorno hemorrágico conocido o coagulopatía.
    13. Sujetos con infección microbiana o viral, que no está controlada por la medicación adecuada. Sujetos con cualquier tipo de infección crónica.
    14. Mujeres embarazadas o que dan el pecho.
    15. Mujeres con capacidad de concebir (WOCBP, definidas como < 2 años después de la última menstruación y no quirúrgicamente estériles) u hombres cuyas parejas sexuales son WOCBP que no quieren o no pueden usar un método anticonceptivo altamente efectivo durante al menos 1 mes antes del ingreso al estudio, durante la duración del estudio y durante al menos 3 a 6 meses después de la última dosis de medicamento del estudio, según el brazo de tratamiento. Ver también la sección 6.1.10.1: Métodos anticonceptivos
    16. Evidencia de trastorno médico grave no controlado o infección activa que, en opinión del investigador o monitor médico, hace que sea indeseable que el sujeto participe en el estudio o que ponga en peligro el cumplimiento del protocolo.
    17. Otras condiciones médicas que, en opinión del investigador, descalifican al sujeto para su inclusión.
    18. Solo para el brazo C:
    18a Líneas anteriores de tratamiento con medicamentos contra el cáncer distinto de la monoterapia con pembrolizumab administrada como 1.ª línea.
    18b Mutación EGFR tumoral conocida, a menos que esté contraindicada para la terapia dirigida por EGFR.
    18c Reestructuración ALK tumoral conocida, a menos que la contraindicación para la terapia dirigida por ALK o la terapia dirigida por ALK no estén disponibles.
    E.5 End points
    E.5.1Primary end point(s)
    Part I and II
    • The incidence of Grade 3 and higher adverse events (AEs) related to CAN04 administration and according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE, version 4.03).
    Partes I y II
    • La incidencia de eventos adversos (AE) de grado 3 y superiores relacionados con la administración de CAN04 y según el Instituto Nacional del Cáncer, Criterios terminológicos comunes para eventos adversos (CTCAE, versión 4.03).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ongoing during the complete trial.
    En curso durante el ensayo completo.
    E.5.2Secondary end point(s)
    Pharmacokinetics
    • Concentration at the end of infusion (Cinf end).
    • Maximum concentration (Cmax).
    • Time taken to reach maximum concentration (tmax).
    • Terminal half-life (t½).
    • Clearance (CL).
    • Apparent volume of distribution during the terminal phase (Vz).
    • Area under the curve from time 0 to infinity (AUC0-∞).
    • Area under the curve from time 0 to time t (AUC0-t).
    • Area under the curve from time 0 to time 24h (AUC0-24)
    • Area under the curve from time 0 to time 168 h (AUC0-168)
    • Mean residence time (MRT).
    • Serum concentration of soluble IL1RAP (sIL1RAP).

    Additional pharmacokinetic endpoint for Part II:
    • Area under the curve from time 0 to tau (AUC0-τ)

    Anti-drug antibodies (ADA) against CAN04
    • Anti-Drug Antibodies (ADA) against CAN04.

    Preliminary signs of efficacy
    • Overall Response Rate (ORR) using irRC and RECIST 1.1; with irRC to be the decision-making criteria.
    • Duration of Response (DoR).
    • Progression Free Survival (PFS) at 12 months and for the duration of the trial
    • Overall Survival (OS) at 12, 24 and 36 months

    Additional endpoints for Part II
    • Health-related QoL as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ - C30; version 3.0).
    • In addition, and ONLY for subjects with NSCLC: Health-related QoL as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC13 (EORTC QLQ - LC13).
    Farmacocinética
    • Concentración al final de la infusión (Cinf end).
    • Concentración máxima (Cmax).
    • Tiempo necesario para alcanzar la concentración máxima (tmax).
    • Vida media terminal (t½).
    • Aclaramiento (CL).
    • Volumen aparente de distribución durante la fase terminal (Vz).
    • Área bajo la curva del tiempo 0 al infinito (AUC0-∞).
    • Área bajo la curva del tiempo 0 al tiempo t (AUC0-t).
    • Área bajo la curva del tiempo 0 al tiempo 24 h (AUC0-24)
    • Área bajo la curva del tiempo 0 al tiempo 168 h (AUC0-168)
    • Tiempo medio de permanencia (MRT).
    • Concentración sérica de la IL1RAP soluble (sIL1RAP).

    Criterios de valoración farmacocinéticos adicionales para la Parte II:
    • Área bajo la curva del tiempo 0 al tau (AUC0-τ)

    Anticuerpos antimedicamentos (ADA) contra CAN04
    • Anticuerpos antimedicamentos (ADA) contra CAN04.

    Signos preliminares de eficacia
    • Tasa de respuesta global (ORR) usando los irRC y los RECIST (criterios de evaluación de la respuesta en tumores sólidos) 1.1; con los irRC como criterios de toma de decisiones.
    • Duración de respuesta (DoR).
    • Supervivencia libre de progresión (PFS) a los 12 meses y durante la duración del estudio
    • Supervivencia general (OS) a los 12, 24 y 36 meses

    Criterios de valoración adicionales para la Parte II
    • La QoL relacionada con la salud evaluada mediante el cuestionario de calidad de vida C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC-QLQ - C30; versión 3.0).
    • Además, y SOLO para sujetos con NSCLC: La QoL relacionada con la salud evaluada mediante el cuestionario de calidad de vida LC13 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC-QLQ - LC13).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the end point. Ongoing during the complete trial.
    Dependiendo del criterio de valoración. En curso durante el ensayo completo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    In Part II: MTD once weekly versus MTD once every 2 weeks versus MTD once weekly/every 2 weeks + SOC
    E.8.2.4Number of treatment arms in the trial5
    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 EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 116
    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
    ninguno
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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