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    EudraCT Number:2021-002566-40
    Sponsor's Protocol Code Number:20200491
    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:2021-10-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-002566-40
    A.3Full title of the trial
    A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 757 in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
    Estudio de fase 2 para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética de AMG 757 en sujetos con cáncer de pulmón microcítico en recaída/refractario después de dos o más líneas de tratamiento previas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of AMG 757 in Patients with Small Cell Lung Cancer (SCLC)
    Estudio de fase 2 de AMG 757 en pacientes con cáncer de pulmón microcítico (CPM)
    A.4.1Sponsor's protocol code number20200491
    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 SponsorAmgen 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen S.A.
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressWTC Barcelona, Moll de Barcelona s/n, Edifici Sud,7ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08039
    B.5.4Telephone number+34936001860
    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 nameAMG 757
    D.3.2Product code AMG 757
    D.3.4Pharmaceutical form Powder 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 INNAMG 757
    D.3.9.3Other descriptive nameAMG 757
    D.3.9.4EV Substance CodeSUB189746
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.4
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Relapsed/Refractory Small Cell Lung Cancer
    Cáncer de pulmón microcítico en recaída/refractario
    E.1.1.1Medical condition in easily understood language
    Relapsed/Refractory Small Cell Lung Cancer
    Cáncer de pulmón microcítico en recaída/refractario
    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 10041070
    E.1.2Term Small cell lung cancer recurrent
    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 1 only
    •To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of AMG 757

    All part
    •Evaluate anti-tumor activity of AMG 757 as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
    Solo en la parte 1
    • Evaluar la seguridad y eficacia (según los criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 [RECIST 1.1] por parte del investigador) de 2 niveles de dosis de AMG 757

    Todas las partes
    • Evaluar la actividad antitumoral de AMG 757 determinada por la tasa de respuesta objetiva (TRO) según los criterios RECIST 1.1 mediante una revisión central enmascarada independiente (RCEI)
    E.2.2Secondary objectives of the trial
    •Evaluate anti-tumor activity of AMG 757 as determined by other measures per RECIST 1.1 by BICR
    •Evaluate anti-tumor activity of AMG 757 as assessed by ORR and other measures per RECIST 1.1 by investigator
    •Evaluate the safety and tolerability of AMG 757
    •Characterize the pharmacokinetics (PK) of AMG 757
    •Evaluate the immunogenicity of AMG 757
    •Evaluar la actividad antitumoral de AMG 757 determinada por otras medidas según los criterios RECIST 1.1 mediante una RCEI
    •Evaluar la actividad antitumoral de AMG 757 determinada por la TRO y otras medidas según los criterios RECIST 1.1 por parte del investigador
    •Evaluar la seguridad y la tolerabilidad de AMG 757
    •Describir la farmacocinética (FC) de AMG 757
    •Evaluar la inmunogenicidad de AMG 757
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
    102 Male and female subjects >= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
    103 Histologically or cytologically confirmed relapsed/refractory SCLC
    104 Subjects who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
    Note: (1) re-treatment with a platinum-based regimen is considered a second line of therapy; (2) platinum-based regimen followed by checkpoint inhibitor/anti-programmed death ligand 1 (PD-L1) as maintenance therapy is considered 1 line of therapy; (3) in countries where standard of care first line systemic treatment includes platinum containing chemotherapy in combination with PD-L1 inhibitor, it is required that patients to have failed PD-L1 inhibitor as part of their first line systemic treatment or not have access to.
    105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded [FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.
    106 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    107 Minimum life expectancy of 12 weeks.
    108 Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first
    dose of AMG 757.
    109 Subjects with treated brain metastases are eligible provided they meet the following criteria:
    - Definitive therapy was completed at least 2 weeks prior to the first dose of AMG 757.
    - There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening. Patients manifesting progression in lesions previously treated with stereotactic radiosurgery may still be eligible if pseudoprogression can be demonstrated by appropriate means and after discussion with the medical monitor.
    - Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.
    110 Adequate organ function, defined as follows:
    hematological function:
    - absolute neutrophil count >= 1 x 10^9/L
    - platelet count >= 100 x 10^9/L
    - hemoglobin > 9 g/dL (90 g/L)
    coagulation function:
    - prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) <= 1.5 x institutional upper limit of normal (ULN). Subjects on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll after discussion with the medical monitor.
    renal function:
    - estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2
    hepatic function:
    - aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 3 X ULN (or < 5 X ULN for subjects with liver involvement)
    - total bilirubin < 1.5 X ULN (or < 2 X ULN for subjects with liver metastases)
    pulmonary function:
    - no clinically significant pleural effusion
    - baseline oxygen saturation > 90% on room air
    cardiac function:
    - cardiac ejection fraction >= 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) findings
    101 El sujeto ha proporcionado su consentimiento informado/asentimiento antes de iniciar cualquier procedimiento/actividad específicos del estudio.
    102 Hombres y mujeres ≥ 18 años (o la mayoría de edad legal en el país) en el momento de firmar el consentimiento informado.
    103 CPM en recaída o refractario confirmado histológica o citológicamente.
    104 Sujetos que han experimentado progresión o recaída después de 1 régimen basado en platino y al menos otra línea de tratamiento previa.
    Nota: (1) el retratamiento con un régimen basado en platino se considera una segunda línea de tratamiento; (2) el régimen basado en platino seguido de un inhibidor de los puntos de control/ligando 1 antimuerte celular programada (PD-L1) como tratamiento de mantenimiento se considera una línea de tratamiento; (3) en los países en los que el tratamiento sistémico de primera línea estándar incluye quimioterapia con platino en combinación con un inhibidor del PD-L1, es necesario que el tratamiento de los pacientes con el inhibidor del PD-L1 haya fracasado como parte de su tratamiento sistémico de primera línea o no tengan acceso a él.
    105 Los sujetos deben estar dispuestos a proporcionar muestras tumorales archivadas (muestra incluida en parafina y fijada con formol [FFPE]) o a someterse a una biopsia tumoral previa al tratamiento. Los sujetos que no dispongan de tejido tumoral archivado y no puedan someterse a una biopsia tumoral previa al tratamiento debido a circunstancias atenuantes (por ejemplo, que no pueda realizarse de forma segura o que sea inaccesible, si así lo determina el investigador) podrán incluirse sin una biopsia tumoral previo acuerdo entre el investigador y el monitor médico de Amgen.
    106 Estado funcional ECOG (Eastern Cooperative Oncology Group) de 0-1.
    107 Esperanza de vida mínima de 12 semanas.
    108 Lesiones medibles según los criterios RECIST 1.1 en los 21 días previos a la primera dosis de AMG 757.
    109 Los sujetos con metástasis cerebrales tratadas son elegibles siempre que cumplan los criterios siguientes:
    - El tratamiento definitivo se ha completado al menos 2 semanas antes de recibir la primera dosis de AMG 757.
    - No existe ninguna evidencia radiográfica de progresión de la enfermedad en el sistema nervioso central (SNC) después del tratamiento definitivo y en el momento de la selección del estudio. Los pacientes que manifiesten progresión en lesiones previamente tratadas con radiocirugía estereotáctica pueden ser elegibles si se puede demostrar seudoprogresión con un medio apropiado y después de comentarlo con el monitor médico.
    - Cualquier enfermedad del SNC que sea asintomática durante al menos 7 días (a no ser que el investigador considere que los síntomas son irreversibles), el paciente no ha tomado esteroides durante al menos 7 días (se permiten dosis fisiológicas de esteroides) y el paciente no ha tomado fármacos antiepilépticos o ha tomado dosis estables de fármacos antiepilépticos para tratar la enfermedad neoplásica del SNC durante al menos 7 días.
    110 Función orgánica adecuada tal como se define a continuación:
    Función hematológica:
    - Recuento absoluto de neutrófilos ≥ 1 x 109/l.
    - Recuento plaquetario ≥ 100 x 109/l.
    - Hemoglobina > 9 g/dl (90 g/l).
    Función coagulante:
    - Tiempo de protrombina (TP)/cociente normalizado internacional (INR) y tiempo de tromboplastina parcial (TTP) o tiempo de tromboplastina parcial activada (TTPa) ≤ 1,5 x límite superior de la normalidad (LSN) del centro. Los sujetos en tratamiento anticoagulante crónico que no cumplan con los criterios anteriores pueden ser elegibles para incluirse después de hablarlo con el monitor médico.
    Función renal:
    - Tasa de filtración glomerular estimada (TFGe) basada en el cálculo de la modificación de la dieta en la enfermedad renal (MDRD)  30 ml/min/1,73 m2.
    Función hepática:
    - Aspartato aminotransferasa (AST), alanina aminotransferasa (ALT) y fosfatasa alcalina (FA) < 3 x LSN (o > 5 x LSN para los sujetos con afectación hepática).
    - Bilirrubina total < 1,5 x LSN (o < 2 x LSN para los sujetos con metástasis hepáticas).
    Función pulmonar:
    - Derrame pleural clínicamente no significativo.
    - Saturación basal de oxígeno > 90 % en el aire ambiental.
    Función cardíaca:
    - Fracción de eyección cardíaca ≥ 50%, sin derrame pericárdico clínicamente significativo determinado por un ecocardiograma (ECO) o una ventriculografía isotópica (MUGA), y sin hallazgos clínicamente significativos en el electrocardiograma (ECG).
    E.4Principal exclusion criteria
    Disease Related
    201 Untreated or symptomatic brain metastases and leptomeningeal disease.
    202 Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
    203 Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
    204 Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible(defined as having been present and stable for > 21 day) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
    Other Medical Conditions
    205 History of other malignancy within the past 2 years, with the following exceptions:
    - malignancy treated with curative intent and with no known active disease
    present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
    - adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    - adequately treated cervical carcinoma in situ without evidence of disease.
    - adequately treated breast ductal carcinoma in situ without evidence of disease.
    - prostatic intraepithelial neoplasia without evidence of prostate cancer.
    - adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
    206 Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757 (Section 11.9).
    207 History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 757.
    208 Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose AMG 757.
    NOTE: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis or have any clinical signs of infection are eligible. Subjects who meet these criteria and who were previously on IV antimicrobials should have been off IV antimicrobials for > 48 hours.
    209 Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter).
    NOTE: A pleural catheter or dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
    210 History of hypophysitis or pituitary dysfunction.
    211 Exclusion of hepatitis infection based on the following results and/or criteria:
    - Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic
    hepatitis B or recent acute hepatitis B).
    - Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary.
    Detectable hepatitis B virus DNA suggests occult hepatitis B.
    - Positive hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C
    212 Major surgery within 28 days of first dose AMG 757.
    213 History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with medical monitor and meeting the following criterion: no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of AMG 757 (counted from day of positive test for asymptomatic subjects)
    Prior/Concomitant Therapy
    214 Subject received prior therapy with AMG 757.
    215 Prior anti-cancer therapy within 28 days prior to first dose of AMG 757.
    - Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade <=1.
    - Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757.
    216 Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757.
    217 Live and live-attenuated vaccines within 4 weeks prior to the start off AMG 757 treatment, during treatment, and until end of last study dose.

    Please refer to protocol for exclusion criteria 218 to 228.
    Relacionados con la enfermedad
    201Metástasis cerebrales no tratadas o sintomáticas y enfermedad leptomeníngea
    202Evidencia de enfermedad pulmonar intersticial o neumonitis no infecciosa activa
    203Sujetos que hayan experimentado neumonitis recurrente de grado≥2 o AA graves e inmunomediados potencialmente mortales o reacciones relacionadas con la perfusión, incluidas las que provoquen la interrupción permanente del tto con agentes inmunooncológicos.
    204Toxicidad no resuelta derivada de un tto antitumoral previo, definida por no haberse resuelto hasta el grado 1 de los criterios terminológicos comunes para AA(CTCAE),versión5.0, o hasta los niveles dictados en los criterios de elegibilidad con la excepción de alopecia o toxicidades derivadas de un tto antitumoral previo que se consideren irreversibles (definidas por haber estado presentes y estables durante >21d)podrán permitirse si no están descritas de ningún otro modo en los criterios de exclusión y el investigador y Amgen han acordado permitirlas.
    Otras enfermedades
    205Antecedentes de otras neoplasias malignas en los últimos 2años, con las excepciones siguientes:
    -Tumor maligno tratado con intención curativa y sin presencia de enfermedad activa confirmada durante≥2años antes de la inclusión y que el médico encargado del tto considere de bajo riesgo de recurrencia
    -Cáncer de piel no melanomatoso o lentigo maligno tratados adecuadamente sin evidencia de enfermedad
    -Carcinoma cervicouterino in situ tratado adecuadamente sin evidencia de enfermedad
    -Carcinoma ductal de mama in situ tratado adecuadamente sin evidencia de enfermedad
    -Neoplasia intraepitelial prostática sin evidencia de cáncer de próstata
    -Carcinoma urotelial papilar no invasivo o carcinoma in situ tratados adecuadamente
    206Infarto de miocardio y/o insuficiencia cardíaca congestiva sintomática (clase>II de la NYHA)durante los 12m anteriores a la 1a D de AMG757(apart.11.9)
    207Antecedentes de trombosis arterial (p.ej.ictus o accidente isquémico transitorio) durante los 12m previos a la 1a D de AMG757
    208Presencia de una infección fúngica, bacteriana, vírica o de otra índole que requiera tto oral o IV con antimicrobianos durante los 7días previos a la 1a D de AMG757.
    NOTA:se permiten infecciones del tracto urinario(ITU) y faringitis bacteriana sin complicaciones si los sujetos responden al tto activo y después de consultarlo con el promotor. Son elegibles los sujetos que requieran antibióticos orales que hayan permanecido afebriles 24horas, no tengan leucocitosis ni presenten ningún signo clínico de infección. Los sujetos que cumplan estos criterios y tratados previamente con antimicrobianos por vía IV deberán dejar de recibirlos>48 horas antes.
    209Presencia de cualquier vía o drenaje permanente (p.ej,tubo de nefrostomía percutánea, catéter de Foley permanente, drenaje biliar o catéter pleural/peritoneal/pericárdico)
    NOTA:se permite el uso de un catéter pleural o de catéteres de acceso venoso central específicos, como un catéter Port-a-Cath o Hickman
    210Antecedentes de hipofisitis o disfunción de la hipófisis
    211Exclusión de la infección por hepatitis según los resultados y/o criterios siguientes:
    -Positivo para el antígeno de superficie de la hepB(HBsAg)(indica hepB crónica o aguda reciente)
    -Negativo para HBsAg y positivo para anticuerpo del núcleo de la hepB:debe determinarse el ADN del virus de la hepB mediante la reacción en cadena de la polimerasa(RCP).El ADN del virus de la hepB detectable sugiere una hepBoculta
    -Positivo para anticuerpos del virus de la hepatitis C(HCVAb):debe determinarse el ARN del virus de la hepC mediante PCR. El ARN del virus de la hepC detectable sugiere una hepC crónica
    212Cirugía mayor en los 28días previos a la 1a D de AMG757
    213Antecedentes o evidencia de infección por el síndrome respiratorio agudo severo por coronavirus tipo 2(SARS-CoV-2),a menos que se haya acordado con el monitor médico y se cumpla el criterio siguiente:ausencia de síntomas agudos de la enfermedad por COVID-19 durante los 14días previos a la 1a D de AMG757(contados a partir del día de la prueba positiva para los sujetos asintomáticos)
    Tto previo/concomitante
    214El sujeto ha recibido tto previo con AMG757
    215Tto anticanceroso previo durante los 28d previos a la 1a D de AMG757.Excepciones:
    -Sujetos que hayan recibido quimioterapia convencional son elegibles si han transcurrido al menos 14d y si toda la toxicidad relacionada con el tto se ha resuelto a grado≤1
    -La radioterapia paliativa previa debe haberse completado al menos 7d antes de la primera D de AMG757
    216Tiene un diagnóstico de inmunodeficiencia o está recibiendo tto sistémico con esteroides o cualquier otra forma de tto inmunosupresor durante los 7d previos a la 1a D de AMG757
    217Vacunas de virus vivos y virus vivos atenuados en las 4semanas previas al inicio del tto con AMG757,durante el tto y hasta el final de la última D del estudio

    Consulte en el protocolo los criterios de exclusión entre 218-228
    E.5 End points
    E.5.1Primary end point(s)
    Part 1 only
    •objective response (OR) (complete response [CR] and partial response [PR])
    •incidence of treatment-emergent adverse events (TEAEs)
    •serum concentrations of AMG 757

    All parts
    •OR (CR and PR)
    Solo en la parte 1
    •Respuesta objetiva (RO) (respuesta completa [RC] y respuesta parcial [RP])
    •Incidencia de acontecimientos adversos aparecidos durante el tratamiento (AADT)
    •Concentraciones séricas de AMG 757

    Todas las partes
    •RO (RC y RP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis is planned when all subjects have been enrolled and have had the opportunity to have at least 6 months of follow up from the first post-baseline tumor assessment.

    The final analysis will occur when enrollment is complete and each subject completes the study, including long-term follow up.
    El análisis principal se planifica cuando todos los sujetos han sido incluidos y han tenido la oportunidad de someterse a como mínimo 6 meses de seguimiento desde la primera evaluación tumoral posbasal.

    El análisis final se llevará a cabo cuando la inclusión haya terminado y todos los sujetos hayan completado el estudio, incluido el seguimiento a largo plazo.
    E.5.2Secondary end point(s)
    •duration of response (DOR)
    •disease control (DC)
    •duration of DC
    •progression-free survival (PFS)
    •overall survival (OS)
    •incidence of TEAEs
    •serum concentrations of AMG 757
    •incidence of anti-AMG 757 antibody formation
    • Duración de la respuesta (DR).
    • Control de la enfermedad (CE).
    • Duración del CE.
    • Supervivencia libre de progresión (SLP).
    • RO.
    • Supervivencia global (SG).
    • Incidencia de AADT.
    • Concentraciones séricas de AMG 757.
    • Incidencia de formación de anticuerpos anti-AMG 757.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis is planned when all subjects have been enrolled and have had the opportunity to have at least 6 months of follow up from the first post-baseline tumor assessment.

    The final analysis will occur when enrollment is complete and each subject completes the study, including long-term follow up.
    El análisis principal se planifica cuando todos los sujetos han sido incluidos y han tenido la oportunidad de someterse a como mínimo 6 meses de seguimiento desde la primera evaluación tumoral posbasal.

    El análisis final se llevará a cabo cuando la inclusión haya terminado y todos los sujetos hayan completado el estudio, incluido el seguimiento a largo plazo.
    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) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Korea, Republic of
    United States
    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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 77
    F.4.2.2In the whole clinical trial 160
    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)
    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 Decision2021-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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