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    Summary
    EudraCT Number:2021-004555-16
    Sponsor's Protocol Code Number:M20-429
    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:2021-12-16
    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 number2021-004555-16
    A.3Full title of the trial
    A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms
    Estudio fase 1b, abierto, de un solo brazo de tratamiento con Epcoritamab en pacientes pediátricos con neoplasias de células B maduras recidivantes/refractarias.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study is to evaluate the safety and pharmacokinetics of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms
    Este estudio evalúa la seguridad y farmacocinética de Epcoritamamb en sujetos pediátricos con neoplasias de células B maduras recidvantes/refractarias
    A.3.2Name or abbreviated title of the trial where available
    Mature B-cell Neoplasms: Phase 1 Study of Epcoritamab in Pediatric Patients
    A.4.1Sponsor's protocol code numberM20-429
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/344/2021
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointGlobal Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901200103
    B.5.6E-mailabbvie_reec@abbvie.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 nameEpcoritamab
    D.3.2Product code ABBV-GMAB-3013
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codeABBV-GMAB-3013
    D.3.9.4EV Substance CodeSUB204090
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEpcoritamab
    D.3.2Product code ABBV-GMAB-3013
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpcoritamab
    D.3.9.1CAS number 2134641-34-0
    D.3.9.2Current sponsor codeABBV-GMAB-3013
    D.3.9.4EV Substance CodeSUB204090
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 Burkitt's or Burkitt-like lymphoma/leukemia, Diffuse large B-cell lymphoma , or other aggressive mature (CD20+) B-cell lymphomas
    Linfoma / leucemia de Burkitt o similar a Burkitt o recidivante / refractario, linfoma difuso de células B grandes u otros linfomas agresivos de células B maduras (CD20 +)
    E.1.1.1Medical condition in easily understood language
    Lymphoma of B-cell origin
    Lymphoma de origen de células B
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10006596
    E.1.2Term Burkitt's lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10003903
    E.1.2Term B-cell lymphoma refractory
    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 10012822
    E.1.2Term Diffuse large B-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are to evaluate the safety and Pharmacokinetic profile of epcoritamab monotherapy in pediatric patients (and young adults) with relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, DLBCL, or other aggressive mature (CD20+) B-cell lymphomas who have failed to reach remission with re-induction therapy or who are unable to receive further consolidation with cell therapy.
    Los objetivos principales del estudio consisten en evaluar el perfil de seguridad y farmacocinética del epcoritamab en monoterapia en pacientes pediátricos (y adultos jóvenes) con linfoma/leucemia de Burkitt o de tipo Burkitt recidivante o resistente, LDCBG u otros linfomas de linfocitos B (CD20+) maduros agresivos que no han logrado la remisión con el tratamiento de reinducción o que no pueden recibir consolidación ulterior con terapia celular.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the preliminary efficacy and immunogenicity of epcoritamab monotherapy.
    El objetivo secundario del estudio es evaluar la eficacia preliminar y la inmunogenicidad de la monoterapia con epcoritamab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects ≥ 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, DLBCL, or other aggressive mature (CD20+) B-cell lymphomas. Patients up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.

    2. Disease pathologically confirmed (tumor tissue) by local testing.

    3. Patients with relapsed or primary refractory disease (as above) meeting any of the following criteria:
    •Progressive disease at any time during second-line chemoimmunotherapy
    •Best response of stable disease (SD) after a minimum of 2 cycles of second-line chemoimmunotherapy
    •Best response of partial response (PR) after a minimum of 3 cycles of second-line chemoimmunotherapy
    •Complete Response after a minimum of 3 cycles of second-line chemoimmunotherapy therapy but unfit or ineligible for consolidation with cell therapy
    •Not in Complete response and unable to initiate or tolerate (i.e., must discontinue) second-line chemoimmunotherapy
    •Have received cell therapy (allogeneic or autologous transplant or CAR-T therapy) as consolidation but have not obtained or maintained a complete response

    4. Recovery from toxic effects of prior chemoimmunotherapy

    5. Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (≥ 16 years old at evaluation) score ≥ 50 or ECOG score ≤ 2

    6. Adequate bone marrow, hepatic, and renal function.

    7. For those patients who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide written informed consent and subject willing and able to give assent, as appropriate for age and country.
    Sujetos de edad ≥1 y <18 años en el momento del diagnóstico primario con linfoma/leucemia de Burkitt o de tipo Burkitt, LDCBG u otros linfomas de linfocitos B (CD20+) maduros agresivos. También podrán participar pacientes de hasta 25 años con linfoma/leucemia de Burkitt o de tipo Burkitt.

    2. Enfermedad confirmada anatomopatológicamente (tejido tumoral) mediante análisis locales.

    3. Pacientes con enfermedad recidivante o resistente primaria (como se ha indicado anteriormente) que cumplan cualquiera de los criterios siguientes:
    • Progresión de la enfermedad en cualquier momento durante la QIT de segunda línea.
    • Mejor respuesta de enfermedad estable (EE) después de un mínimo de 2 ciclos de QIT de segunda línea.
    • Mejor respuesta de respuesta parcial (RP) después de un mínimo de 3 ciclos de QIT de segunda línea.
    • RC después de un mínimo de 3 ciclos de QIT de segunda línea, pero el paciente no es apto para recibir consolidación con terapia celular.
    • Ausencia de RC e incapacidad de iniciar o tolerar (es decir, debe suspenderse) la QIT de segunda línea.
    • Recepción previa de terapia celular (alo o autotrasplante o terapia CAR-T) como consolidación, pero sin haber obtenido o mantenido una RC.

    4. Recuperación de los efectos tóxicos de la quimioinmunoterapia previa.

    5. Estado funcional según la puntuación de Lansky (edad <16 años en el momento de la evaluación) o Karnofsky (edad ≥16 años en el momento de evaluación) ≥50 o según la puntuación del ECOG ≤2.

    6. Función medular, hepática y renal adecuada

    7. En los pacientes que no hayan alcanzado la edad de consentimiento, progenitor o tutor legal con voluntad y capacidad de otorgar su consentimiento informado por escrito y paciente con voluntad y capacidad de otorgar su asentimiento, según proceda, para la edad y el país.
    E.4Principal exclusion criteria
    1. Known CNS involvement by lymphoma at screening as confirmed by screening MRI/CT/PET brain scans (patients with evidence of CNS disease only in the CSF will be eligible).

    2. Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.

    3. Other malignancy requiring therapy.
    1.afectación conocida del SNC por el linfoma en el periodo de selección, confirmado mediante la RM/TC/PET cerebral de selección (solo podrán participar pacientes con signos de afectación del SNC en el LCR).

    2.estar recibiendo actualmente tratamiento antineoplásico, como quimioterapia (excepto tratamiento intratecal), radioterapia, moléculas pequeñas, anticuerpos monoclonales, terapia celular u otros fármacos experimentales.

    3. Otra neoplasia maligna que requiera tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are safety and tolerability, including adverse events of special interest (AESIs) of Cytokine Release Syndrome (CRS), Immune Cell-Associated Neurotoxicity Syndrome (ICANS), and Clinical Tumor Lysis Syndrome (CTLS), and PK parameters of epcoritamab monotherapy.
    Los criterios de valoración principales son la seguridad y la tolerabilidad, incluidos los acontecimientos adversos de interés especial (AAIE) de síndrome de liberación de citocinas (SLC), síndrome de neurotoxicidad asociada a células inmunitarias (SNACI) y síndrome de lisis tumoral clínico (SLTC), así como los parámetros farmacocinéticos de epcoritamab en monoterapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and tolerability are evaluated throughout the study.

    Pharmacokinetic parameters are evaluated the following timepoint:
    • Cycle 1: Day 10, Day 15-17, Day 19, Day 22
    •Cycle 2: Day 1, Day 8-10, Day 12, Day 15
    •Cycle 3-10: Day 1
    La seguridad y la tolerabilidad se evalúan a lo largo del estudio.

    Los parámetros farmacocinéticos se evalúan en el siguiente período de tiempo:
    •Ciclo 1: Día 10, Día 15-17, Día 19, Día 22
    •Ciclo 2: Día, Día 8-10, Día 12, Día 15
    •Ciclo 3-10: Día 1
    E.5.2Secondary end point(s)
    •Complete response rate (CR) per the International Pediatric Non- Hodgkin Lymphoma Response Criteria
    •Event free survival (EFS)
    •Overall survival (OS)
    •Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy
    •Overall Response (OR)
    •Duration of response (DOR)
    •Duration of complete response (DOCR)
    •Immunogenicity (antidrug antibody [ADA] and neutralizing anti-drug antibodies [nAb])
    • CR per the International Pediatric Non-Hodgkin Lymphoma
    Response Criteria
    • Supervivencia sin episodios (SSE).
    • Supervivencia global (SG).
    • Tasa de inicio de trasplante de células madre o de terapia CAR-T (linfocitos T con receptores antigénicos quiméricos).
    • Respuesta global (RG).
    • Duración de la respuesta (DR).
    • Duración de la RC (DRC).
    • Inmunogenicidad (anticuerpos contra el fármaco [ACF] y anticuerpos contra el fármaco neutralizantes [AcN]).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease evaluation (CT/MRI/PET) will be performed for all patients prior to administration of epcoritamab on Day 1 and at the following time points relative to Day 1: W6, W12, W24, W36, W48, 18 months, and 24 months, as well as prior to initiation of subsequent therapy, and as clinically indicated. Patients who do not attain a CR during therapy with epcoritamab will have additional disease assessments at W18, W30, W42, and every 3 months thereafter. Patients will be followed for a minimum of 3 years after enrollment.
    Se realizará una evaluación de la enfermedad (TC/RM/PET) en todos los pacientes antes de la administración de epcoritamab el día 1 y en los momentos siguientes con respecto al día 1: S6, S12, S24, S36, S48, 18 y 24 meses, así como antes del inicio del tratamiento posterior y cuando esté clínicamente indicado. Los pacientes que no logren una RC durante el tratamiento con epcoritamab se someterán a evaluaciones adicionales de la enfermedad en las semanas 18, 30 y 42 y, posteriormente, cada tres meses. Los pacientes serán objeto de seguimiento durante un mínimo de 3 años después de su inclusión
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b
    E.7.2Therapeutic exploratory (Phase II) No
    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 Yes
    E.8.1.7.1Other trial design description
    single-arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Australia
    Canada
    Czechia
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end-of-study is defined as the date of the last subject's last visit or date of the last follow-up contact, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 15
    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)
    Upon completion of the study, the subjects will be treated in accordance with the Investigator's best clinical judgement
    Una vez finalizado el estudio, los sujetos serán tratados de acuerdo con el mejor juicio clínico del investigador.
    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 Decision2022-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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