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    Summary
    EudraCT Number:2021-002264-41
    Sponsor's Protocol Code Number:IMGC936-0901
    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:2021-09-20
    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 number2021-002264-41
    A.3Full title of the trial
    A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936-0901 (Anti-ADAM9 Antibody Drug Conjugate) in Patients with Advanced Solid Tumors
    Un estudio de fase 1/2, primero en humanos, de etiqueta abierta, de escalada y expansión de dosis de IMGC936-0901 (conjugado de fármaco de anticuerpo anti-ADAM9) en pacientes con tumores sólidos avanzados.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors
    Estudio del medicamento IMGC936 (primera vez que se prueba en personas) en pacientes con tumores sólidos avanzados
    A.3.2Name or abbreviated title of the trial where available
    First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors
    A.4.1Sponsor's protocol code numberIMGC936-0901
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04622774
    A.5.4Other Identifiers
    Name:IND NumberNumber:141340
    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 SponsorImmunoGen, 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 supportImmunoGen, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunoGen, Inc.
    B.5.2Functional name of contact pointKenneth Dhimitri
    B.5.3 Address:
    B.5.3.1Street Address830 Winter Street
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number001781207-5341
    B.5.6E-mailregulatory.affairs@immunogen.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 nameIMGC936
    D.3.2Product code IMGC936
    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 INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeIMGC936
    D.3.9.3Other descriptive nameIMGC936
    D.3.9.4EV Substance CodeSUB234809
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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) 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
    Advanced Solid Tumors
    Tumores sólidos avanzados
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors
    Tumores sólidos avanzados
    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 LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous 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 10075566
    E.1.2Term Triple negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic cancer
    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
    Dose Expansion Phase:
    • To describe ORR for IMGC936 using RECIST v1.1
    Fase primaria de expansión de dosis:
    • Describir la TRO para IMGC936 utilizando RECIST vl.1
    E.2.2Secondary objectives of the trial
    • To assess safety and tolerability for IMGC936
    • To characterize PK and immunogenicity of IMGC936
    • To describe DoR and PFS
    • Caracterizar la seguridad y tolerabilidad de IMGC936
    • Caracterizar la farmacocinética (PK) y la inmunogenicidad de IMGC936.
    • Describir la DR y SSP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to provide informed consent and documentation of informed consent prior to any study-related tests or procedures that are not part of standard of care for the participant’s disease. Participants must be willing and able to comply with study procedures.
    2. Participants with histologically proven, relapsed or refractory, unresectable locally advanced or metastatic non-squamous NSCLC, TNBC, CRC, gastroesophageal cancer, or pancreatic cancer for whom no therapy with demonstrated clinical benefit is available.
    Note: Neoadjuvant/adjuvant systemic treatment are included in prior lines of therapy, except for TNBC where they are excluded.
    Note: Maintenance therapies are considered part of the prior line of therapy and will not be counted as a separate line of therapy.
    a. NSCLC: Participants must have been treated with 1 to 4 prior lines of systemic therapy with no more than 2 chemotherapy containing lines.
    b. TNBC: Participants must have been treated with 1 to 4 prior lines of systemic therapy for metastatic disease, excluding adjuvant therapies.
    c. CRC: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
    d. Gastroesophageal cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy.
    e. Pancreatic cancer: Participants must have been treated with 1 to 3 prior lines of systemic therapy, with no more than 2 chemotherapy containing lines.
    3. Either non-measurable or measurable disease per RECIST v1.1 and documented by CT and/or MRI obtained within 28 days of C1D1.
    a. Dose Escalation Phase: Participants may have non-measurable or measurable disease per RECIST v1.1.
    b. Dose Expansion Phase: Participants must have measurable disease per RECIST v1.1.
    4. Age > or = 18 years old.
    5. Archival FFPE tissue must be available. Participants may undergo a fresh tumor biopsy using a low-risk, medically routine procedure to obtain a specimen for testing if a archival tumor sample is not available.
    a. Tumor specimens for retrospective determination of ADAM9 expression via IHC staining will be collected from all participants and will be assayed at a central laboratory designated by the sponsor.
    6. ECOG performance status of 0 or 1.
    a. If ECOG performance status is an inappropriate performance measurement for participant enrollment (eg, chronically non-ambulatory), then Karnofsky performance status must be > or = 70.
    7. Life expectancy > or = 12 weeks.
    8. Acceptable laboratory parameters as follows:
    • Platelet count > or = 75 × 1^3/microL without platelet transfusion within 28 days prior to initiation of study drug.
    • Absolute neutrophil count > or = 1.5 × 1^3/microL in the absence of any growth factor support within 21days prior to initiation of study drug.
    • ALT/AST < or = 3.0 × ULN; for participants with hepatic metastases, ALT and AST < or = 5 × ULN.
    • Total bilirubin ≤ 1.5 × ULN, except participants with Gilbert’s syndrome, who may enroll if the conjugated bilirubin is within normal limits.
    • eGFR > 30 mL/min/1.73 m^2 or an estimated creatinine clearance of > 30 mL/min.
    • Urinalysis protein and white occult blood cells within normal limits.
    • Negative serum pregnancy test for FOCBP.
    9. FOCBP, defined as not surgically sterilized (hysterectomy, bilateral salpingectomy, and
    bilateral oophorectomy) and between menarche and 1-year post menopause, must have a
    negative serum pregnancy test performed within 72 hours prior to initiation of study drug
    administration. Female participants must abstain from egg donation during the study.
    10. FOCBP and male participants with partners of FOCBP must agree to use highly effective methods of contraception, according to protocol Section 8.1.3, from the time of consent through 28 weeks after discontinuation of study drug administration. Male participants must abstain from sperm donation during the study.
    11. FOCBP is not pregnant or breastfeeding, or a male participant is not expecting to father children within the projected duration of the study, starting with screening visit through 28 weeks after the last dose of study drug.
    1. Capacidad de proporcionar un consentimiento informado y documentación del mismo antes de cualquier prueba o procedimiento relacionado con el estudio que no forme parte de la atención estándar para la enfermedad del participante. Los participantes deben estar dispuestos y ser capaces de cumplir con los procedimientos del estudio.
    2. Participantes con CPCNP no escamoso, histológicamente comprobado, recidivante o refractario, localmente avanzado o metastásico, TNBC, CCR, cáncer gastroesofágico o cáncer de páncreas para los que no se disponga de una terapia con beneficio clínico demostrado. Nota: El tratamiento sistémico neoadyuvante/adyuvante se incluye en las líneas de terapia previas, excepto en el caso del TNBC, donde se excluye.
    Nota: Las terapias de mantenimiento se consideran parte de la línea de terapia previa y no se contarán como una línea de terapia independiente. CPCNP: Los participantes deben haber sido tratados con 1 a 4 líneas previas de terapia sistémica con no más de 2 líneas que contengan quimioterapia.
    a. TNBC: Los participantes deben haber sido tratados con 1 a 4 líneas previas de terapia sistémica o enfermedad metastásica, excluyendo las terapias adyuvantes.
    b. CRC: Los participantes deben haber sido tratados con 1 a 3 líneas previas de terapia sistémica.
    c. Cáncer gastroesofágico: Los participantes deben haber sido tratados con 1 a 3 líneas anteriores de terapia sistémica.
    d. Cáncer de páncreas: Los participantes deben haber sido tratados con 1 a 3 líneas previas de terapia sistémica, con no más de 2 líneas que contengan quimioterapia.
    3. Enfermedad no medible o medible según RECIST v1.1 y documentada por tomografía computarizada (TC) y/o resonancia magnética (RM) obtenida en los 28 días siguientes a la C1D1
    a. Fase de escalada de dosis: Los participantes pueden tener enfermedad no medible o medible según RECIST v1.1.
    b. Fase de expansion de dosis: Los participantes deben tener enfermedad medible según RECIST v1.1.
    4. Edad > o = 18 años
    5. Debe haber tejido fijado con formalina e incrustado en parafina (FFPE) disponible. Los participantes pueden someterse a una biopsia tumoral en fresco mediante un procedimiento de bajo riesgo y de rutina médica para obtener una muestra para las pruebas si no se dispone de una muestra tumoral de archivo.
    a. Se recogerán muestras de tumores de todos los participantes para la determinación retrospectiva de la expresión de ADAM9 mediante coloración IHC y se analizarán en un laboratorio central designado por el patrocinador.
    6. Estado de rendimiento del Grupo Cooperativo de Oncología del Este (ECOG) de 0 o 1.
    a. Si el estado de rendimiento ECOG es una medida de rendimiento inadecuada para la inscripción de los participantes (p. ej., no ambulatorios crónicos), entonces el estado de rendimiento Karnofsky debe ser ≥ 70.
    7. Esperanza de vida > o = 12 semanas.
    8. Parámetros de laboratorio aceptables a continuación:
    • Recuento de plaquetas > o = 75 × 10^3/microL sin transfusión de plaquetas en los 28 días anteriores al inicio del fármaco del estudio
    • Recuento absoluto de neutrófilos > o = 1,5 × 10^3/microL en ausencia de cualquier apoyo de factor de crecimiento dentro de los 21 días anteriores al inicio del fármaco del estudio
    • ALT/AST < o = 3,0 × ULN; para los participantes con metástasis hepáticas, ALT y AST< o =5×ULN.
    • Bilirrubina total < o = 1,5 × ULN, excepto los participantes con síndrome de Gilbert, que pueden inscribirse si la bilirrubina conjugada está dentro de los límites normales
    • Tasa de filtración glomerular estimada (TFGe) >30mL/min/1,73m2 o un aclaramiento de creatinina estimado de >30 mL/min
    • Análisis de orina con proteínas y glóbulos blancos ocultos dentro de los límites normales
    • Prueba de embarazo en suero negativa para mujeres en edad fértil (FOCBP)
    9. Las mujeres FOCBP, definidas como no esterilizadas quirúrgicamente (histerectomía, salpingectomía bilateral y ooforectomía bilateral) y entre la menarquia y un año después de la menopausia, deben tener una prueba de embarazo sérica negativa realizada dentro de las 72 horas anteriores al inicio de la administración del medicamento del estudio. Las participantes deben abstenerse de donar óvulos durante el estudio.
    10. Las participantes FOCBP y los participantes masculinos con parejas FOCBP deben aceptar utilizar métodos anticonceptivos altamente eficaces, según la Sección 8.1.3, desde el momento del consentimiento hasta 28 semanas después de la interrupción de la administración del medicamento del estudio. Los participantes masculinos deben abstenerse de donar esperma durante el estudio
    11. FOCBP no embarazada ni en período de lactancia, o un participante masculino no está esperando tener hijos dentro de la duración prevista del estudio, comenzando con la visita de selección hasta 28 semanas después de la última dosis del medicamento del estudio
    E.4Principal exclusion criteria
    1. Participants with active central nervous system (CNS) disease within the last 6 months.
    2. Active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision.
    3. Participants who had prior therapies within the specified times below:
    • Systemic antineoplastic therapy within at least 5 half-lives or 4 weeks (whichever is shorter) prior to initiation of study drug.
    • Mediastinal or pelvic radiation therapy within 6 weeks prior to initiation of study drug administration. Palliative, limited field radiation for symptom control to soft tissues, or bone lesions within 2 weeks prior to initiation of study drug.
    − Note: Previously irradiated lesions are not considered measurable disease unless they have demonstrated progression per RECIST v1.1.
    4. Participants must have stabilized or recovered (Grade 1 or baseline) from all priortherapy-related toxicities (except alopecia).
    5. Clinically significant cardiovascular disease including but not limited to:
    • Myocardial infarction or unstable angina within 6 months prior to initiation of study drug.
    • Stroke or transient ischemic attack within 6 months prior to initiation of study drug.
    • Current clinically significant cardiac arrhythmias, eg, atrial fibrillation that are not well controlled with optimal medical intervention.
    • Current uncontrolled hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg.
    • Current congestive heart failure (New York Heart Association class III-IV).
    • Current pericarditis or clinically significant pericardial effusion.
    • Current myocarditis.
    • LVEF of < 50% by scan.
    • QTc interval > 480 msec.
    6. Clinically significant pulmonary compromise, including pneumonia, pneumonitis, or a requirement for supplemental oxygen (excluding for sleep apnea) or history of ≥ Grade 3 drug-induced or radiation pneumonitis.
    7. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
    • Active hepatitis B or C infection (whether or not on active antiviral therapy).
    • Human immunodeficiency virus infection.
    • Cytomegalovirus infection.
    • Active COVID-19/SARS-CoV-2 infection. While SARS-CoV-2 testing is not mandatory for study entry, testing should follow local clinical practice guidelines/standards.
    • Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to initiation of study drug.
    Note: Testing at screening is not required for the above infections unless clinically indicated.
    8. History of prior bone marrow, stem cell, or solid organ transplantation.
    9. Second primary invasive malignancy that has not been in remission for greater than 2 years, except nonmelanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ or similar.
    10. Major trauma or major surgery within 4 weeks prior to initiation of study drug.
    11. Any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the study site.
    12. Prior life-threatening hypersensitivity reactions to antibodies or any excipient contained in the drug formulation.
    13. Vaccination with replication-competent live virus vaccine within 4 weeks prior to initiation of study drug. Not all vaccine adverse effects have resolved to Grade 1. Inactivated annual influenza non-live vaccination is allowed.
    1. Participantes con enfermedad activa del sistema nervioso central (SNC) en los últimos 6 meses
    2. Trastornos corneales activos o crónicos, antecedentes de trasplante de córnea o afecciones oculares activas que requieran tratamiento/monitoreo continuo, como glaucoma no controlado, degeneración macular húmeda relacionada con la edad que requiera inyecciones intravítreas, retinopatía diabética activa con edema macular, degeneración macular, presencia de papiledema y/o visión monocular
    3. Participantes que hayan recibido terapias previas dentro de los plazos especificados a continuación:
    a. Terapia antineoplásica sistémica en un plazo de al menos 5 semividas o 4 semanas (lo que sea más corto) antes del inicio del medicamento del estudio
    b. Radioterapia mediastínica o pélvica en las 6 semanas anteriores al inicio de la administración del medicamento del estudio. Radiación paliativa de campo limitado para el control de los síntomas en tejidos blandos o lesiones óseas en las 2 semanas
    anteriores al inicio del medicamento del estudio. - Nota: Las lesiones previamente irradiadas no se consideran enfermedad medible a menos que hayan demostrado progresión según RECIST v1.1.
    4. Los participantes deben haberse estabilizado o recuperado (grado 1 o base) de todas las toxicidades relacionadas con la terapia anterior (excepto la alopecia)
    5. Enfermedad cardiovascular clínicamente significativa, incluyendo, pero sin limitarse a:
    • Infarto de miocardio o angina inestable en los 6 meses anteriores al inicio del medicamento del estudio
    • Accidente cerebrovascular o ataque isquémico transitorio en los 6 meses anteriores al inicio del medicamento del estudio
    • Arritmias cardíacas clínicamente significativas actuales, por ejemplo, fibrilación auricular que no estén bien controladas con una intervención médica óptima
    • Hipertensión actual no controlada: presión arterial sistólica > 160 mmHg, presión arterial diastólica > 100 mmHg
    • Insuficiencia cardíaca congestiva actual (clase III-IV de la New York Heart Association)
    • Pericarditis actual o derrame pericárdico clínicamente significativo
    • Miocarditis actual
    • Fracción de eyección del ventrículo izquierdo (FEVI) < 50 % en la exploración
    • Intervalo QTc > 480 mseg.
    6. Compromiso pulmonar clínicamente significativo, incluyendo neumonía, neumonitis o necesidad de oxígeno suplementario (excluyendo la apnea del sueño) o historia de neumonitis de grado 3 inducida por medicamentos o por radiación.
    7. Participantes con enfermedades concurrentes graves o infecciones activas clínicamente relevantes, incluyendo, pero sin limitarse a las siguientes:
    • Infección activa por hepatitis B o C (con o sin tratamiento antiviral activo)
    • Infección por el virus de la inmunodeficiencia humana
    • Infección por citomegalovirus
    • Infección activa por COVID-19/SARS-CoV-2. Aunque la prueba del SARS-CoV-2 no es obligatoria para entrar en el estudio, las pruebas deben seguir las directrices/estándares de la práctica clínica local
    • Cualquier otra enfermedad infecciosa concurrente que requiera antibióticos por vía intravenosa en las 2 semanas anteriores al inicio del fármaco del estudio
    - Nota: No es necesario realizar pruebas en el momento de la selección para las infecciones mencionadas, a menos que esté clínicamente indicado
    8. Antecedentes de trasplante previo de médula ósea, células madre u órganos sólidos.
    9. Segunda neoplasia maligna primaria que no haya estado en remisión durante más de 2 años, excepto cáncer de piel no melanoma; carcinoma cervical in situ en la biopsia; o lesión escamosa intraepitelial en la citología; cáncer de próstata localizado (puntuación de Gleason <6); o melanoma in situ resecado o similar.
    10. Traumatismo mayor o cirugía mayor dentro de las 4 semanas anteriores al inicio del medicamento del estudio.
    11. Cualquier condición médica o psiquiátrica grave subyacente que pueda perjudicar la capacidad del participante para recibir o tolerar el tratamiento previsto en el centro del estudio.
    12. Reacciones previas de hipersensibilidad a los anticuerpos o a cualquier excipiente contenido en la formulación del fármaco que pongan en peligro la vida.
    13. Vacunación con una vacuna de virus vivo de replicación competente en las 4 semanas anteriores al inicio del medicamento del estudio. No todos los efectos adversos de la vacuna se han resuelto al grado 1. Se permite la vacunación anual contra la gripe inactivada no viva.
    E.5 End points
    E.5.1Primary end point(s)
    • ORR
    TRO
    E.5.1.1Timepoint(s) of evaluation of this end point
    From screening to end of study (approximately up to 2 years) for each patient.
    Desde selección hasta el final del estudio (aproximadamente 2 años) para cada paciente
    E.5.2Secondary end point(s)
    • Incidence of AEs, SAEs, and study drug–related TEAEs that lead to discontinuation
    • Study drug concentration
    • Summary PK Parameters
    • Incidence ADA
    • DoR
    • PFS
    - Incidencia de AA, AAG y AA relacionados con el medicamento del estudio que lelvan a la interrupción
    - Concentración del medicamento del estudio
    - Resumen de los parámetros FC
    - Incidencia ADA
    - DDR
    - SLP
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Safety: From screening to end of study (approximately up to 2 years) for each participant
    • Study drug concentration: Cycles 1 and 3, Cycles 2,4,5 and 6, and every 3 cycles after cycle 6 until end of study (approximately up to 2 years).
    • Summary of PK parameters: every 3 cycles after Cycle 6 until end of study (approximately up to 2 years).
    • Incidence ADA: Cycles 1 and 3, Cycles 2,4,5 and 6, and every 3 cycles after cycle 6 until end of study (approximately up to 2 years).
    • DoR: From screening to end of study (approximately up to 2 years) for each participant
    • PFS: From screening to end of study (approximately up to 2 years) for each participant
    - Seguridad: Desde selección hasta el final del estudio (aproximadamente hasta 2 años) para cada participante
    - Concentración del medicamento del estudio: Ciclos 1 y 3, ciclos 2,4,5 y 6, y cada 3 ciclos después del ciclo 6 hasta el final del estudio (aproximadamente hasta 2 años).
    - Resumen de los parámetros FC: cada 3 ciclos después del ciclo 6 hasta el final del estudio (aproximadamente hasta 2 años).
    - Incidencia ADA: Ciclos 1 y 3, Ciclos 2,4,5 y 6, y cada 3 ciclos después del ciclo 6 hasta el final del estudio (aproximadamente hasta 2 años).
    - DDR: Desde selección hasta el final del estudio (aproximadamente hasta 2 años) para cada participante
    - SLP: Desde selección hasta el final del estudio (aproximadamente hasta 2 años) para cada participante
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 250
    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)
    Participants will return to standard care.
    Los participantes serán tratados según el estándard de tratamiento
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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