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    Summary
    EudraCT Number:2018-003716-47
    Sponsor's Protocol Code Number:GCT1042-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2020-11-19
    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 number2018-003716-47
    A.3Full title of the trial
    A first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1042 in subjects with malignant solid tumors
    Primer ensayo en humanos, abierto, de aumento escalonado de la dosis con cohortes de ampliación para evaluar la seguridad de GEN1042 en sujetos con tumores sólidos malignos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GEN1042 safety trial in patients with malignant solid tumors
    Ensayo de seguridad GEN1042 en pacientes con tumores sólidos malignos
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberGCT1042-01
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4533779678
    B.5.6E-mailclinicaltrials@genmab.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 nameDuoBody- CD40xCD137
    D.3.2Product code GEN1042
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNGEN1042 (DuoBody-CD40x4-1BB)
    D.3.9.1CAS number 2253891-70-0
    D.3.9.2Current sponsor codeDuoBody-CD40xCD137
    D.3.9.3Other descriptive nameGEN1042
    D.3.9.4EV Substance CodeSUB195352
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    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
    Malignant solid tumors:

    Patients with relapsed or refractory, advanced and/or metastatic melanoma, Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC) who are not anymore candidates for standard therapy
    Tumores sólidos malignos:

    Pacientes con melanoma en recaída o refractario, avanzado y / o metastásico, cáncer de pulmón de células no pequeñas (NSCLC) o cáncer colorrectal (CCR) que ya no son candidatos para la terapia estándar
    E.1.1.1Medical condition in easily understood language
    patients with advanced and/or metastatic melanoma, non-small cell lung cancer, colorectal cancer
    pacientes con melanoma avanzado y / o metastásico, cáncer de pulmón de células no pequeñas, cáncer colorrectal
    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 LLT
    E.1.2Classification code 10065143
    E.1.2Term Malignant solid tumour
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
    - Establish the safety profile of GEN1042
    • Determinar la dosis máxima tolerada (DMT) o la dosis recomendada para la fase II (DRFII)

    • Determinar el perfil de seguridad de GEN1042
    E.2.2Secondary objectives of the trial
    - Establish the PK profile of GEN1042
    - Evaluate immunogenicity of GEN1042
    - Evaluate the anti-tumor activity of GEN1042
    • Determinar el perfil farmacocinético de GEN1042
    • Evaluar el potencial inmunógeno de GEN1042
    • Evaluar la actividad antineoplásica de GEN1042
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Both Dose Escalation and Expansion
    • Subject must have measurable disease according to RECIST 1.1.
    • Subject must have Eastern Cooperative Oncology Group (ECOG) 0-1.
    • Subject must have adequate organ and bone marrow function as defined in protocol.
    For Dose Escalation:
    • Subjects must have a histologically or cytologically confirmed non-CNS solid tumor that is metastatic or unresectable and for whom there is no available standard therapy.
    For Expansion:
    • Subjects must have histologically or cytological confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, CRC cancer who are not anymore candidates for standard therapy.
    Tanto para el aumento escalonado de la dosis como para la ampliación
    • Los sujetos deben presentar síntomas de enfermedad mensurables según RECIST v1.1.
    • Los sujetos deben presentar un estado funcional del Grupo Oncológico Cooperativo de la Costa Este de los EE. UU. (ECOG) de 0 a 1.
    • El sujeto debe tener una función orgánica adecuada y médula ósea según se define en el protocolo.
    Para el escalado de la dosis:
    • El sujeto debe tener un tumor sólido que no afecte al SNC, confirmado mediante histología o citología para el que no se dispone de un tratamiento de referencia.
    Para expansión:
    • Los sujetos deben tener un diagnóstico confirmado mediante histología o citología de melanoma, CPNM o CCR recidivante o resistente, avanzado o metastásico que ya no son aptos para el tratamiento de referencia
    E.4Principal exclusion criteria
    •Subject has uncontrolled intercurrent illness, including but not limited
    to:
    • Ongoing or active infection requiring intravenous treatment with antiinfective therapy that has been administered less than 2 weeks prior
    to first dose
    • Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris or cardiac
    arrhythmia.
    • Uncontrolled hypertension defined as systolic blood pressure ≥ 160
    mmHg and/or diastolic blood pressure ≥ 100 mmHg, despite optimal
    medical management.
    • Subjects with a history of grade 3 or higher irAEs that led to
    treatment discontinuation of a checkpoint inhibitor should be excluded.
    Subjects with irAEs below grade 3 that led to discontinuation should be
    discussed with the sponsor.
    • History of liver disease (e.g., alcoholic hepatitis or non-alcoholic steatohepatitis (NASH), drug-related or auto-immune hepatitis.
    • History of non-infectious pneumonitis that has required steroids or
    currently has pneumonitis.
    • History of organ allograft (except for corneal transplant) or
    autologous or allogeneic bone marrow transplant, or stem cell rescue
    within 3 months prior to the first dose of GEN1042.
    • Serious, non-healing wound, skin ulcer (of any grade), or bone
    fracture.
    • Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or progressive brain metastases or stroke.
    • Prior therapy:
    • Radiotherapy: Radiotherapy within 14 days prior to first GEN1042
    administration. Palliative radiotherapy will be allowed.
    • Unless otherwise noted, treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration. The use of RANK-L inhibitors and bisphosphonates (if on a stable dose for at least 4 weeks) is permitted while participating in this trial. However, the initiation of growth factors and bisphosphonates is not allowed during the first 4 weeks of GEN1042 treatment, unless agreed upon by the investigator and medical monitor.
    • Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to grade 1 or less with the exception of alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia,
    hyperthyroidism, hypothyroidism, and
    peripheral neuropathy must have recovered to ≤ grade 2.
    El sujeto presenta una enfermedad intercurrente no controlada, lo que incluye, entre otras:
    • Infección en curso o activa que requiera tratamiento intravenoso (i.v.) con una terapia antiinfecciosa que se haya administrado menos de 2 semanas antes de la primera dosis.
    • Insuficiencia cardíaca congestiva sintomática (clase III/IV de la Asociación Cardiológica de Nueva York), angina de pecho inestable o arritmia cardíaca.
    • Hipertensión no controlada definida como presión arterial sistólica ≥ 160 mmHg o presión arterial diastólica ≥ 100 mmHg, a pesar de un abordaje médico óptimo.
    • Sujetos con antecedentes de AAri de grado 3 o superior que causaron la discontinuación del tratamiento previo con un inhibidor del PCI. Se deberá consultar al promotor sobre los sujetos con AAri inferiores a grado 3 que causaran la discontinuación.
    • Antecedentes de enfermedad hepática (p. ej., hepatitis alcohólica o esteatohepatitis no alcohólica [EHNA], hepatitis relacionada con el fármaco o autoinmunitaria).
    • Antecedentes de neumonitis no infecciosa que requiriera el uso de corticoesteroides o neumonitis actual.
    • Antecedentes de alotrasplante de órganos (excepto en el caso de trasplante de córnea) o autotrasplante o trasplante alogénico de médula ósea o rescate con células madre en los 3 meses previos a la primera dosis de GEN1042.
    • Heridas graves, que no cicatrizan, úlceras en la piel (de cualquier grado) o fractura ósea.
    • Antecedentes de malformación arteriovenosa intracerebral, aneurisma cerebral, metástasis cerebral progresiva o accidente cerebrovascular.
    Tratamiento previo:
    • Radioterapia en los 14 días previos a la primera administración de GEN1042 (se permitirá la radioterapia paliativa).
    • A menos que se indique lo contrario, tratamiento con agente antineoplásico (en los 21 días o para los tratamientos generalizados después de al menos 5 semividas del fármaco, lo que sea más corto), antes de la administración de GEN1042. Se permite el uso de inhibidores del RANK-L y bisfosfonatos (si se encuentran en una dosis estable durante al menos 4 semanas) mientras se participa en este ensayo. No obstante, no se permite el inicio de factores de crecimiento y bisfosfonatos durante las primeras 4 semanas del tratamiento con GEN1042, a menos que así lo acuerden el investigador y el monitor médico.
    • Toxicidades por tratamientos antineoplásicos previos que no hayan vuelto a los niveles basales o al grado 1 o inferior a excepción de alopecia, anorexia, vitíligo, fatiga, tiroiditis activa y neuropatía periférica. La anorexia, el hipertiroidismo, el hipotiroidismo y la neuropatía periférica deben haberse resuelto a un grado ≤ 2.
    E.5 End points
    E.5.1Primary end point(s)
    - Dose-limiting toxicity (DLT)
    - Adverse events (AEs) and safety laboratory parameters
    • Toxicidad limitante de la dosis (TLD)
    • Acontecimientos adversos (AA) y parámetros analíticos de seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLTs: dose limiting toxicities will be collected for the first cycle i.e. DLT period of 3 weeks (21 days).
    AEs: screening; Day 1, 2, 3, 8, 15 during Cycles 1-2; Days 1, 8, 15 during Cycles 3-6, Day 1 subsequent Cycles (7-PD); EoT; 4, 8, 12, subsequent
    every 12 (survival follow-up) Weeks after last dosing.
    DLT: las toxicidades limitantes de la dosis se recopilarán para el primer ciclo, es decir, un período de DLT de 3 semanas (21 días).
    EA: cribado; Día 1, 2, 3, 8, 15 durante los Ciclos 1-2; Días 1, 8, 15 durante los Ciclos 3-6, Ciclos posteriores del Día 1 (7-PD);
    EoT; 4, 8, 12, posteriores cada 12 (seguimiento de supervivencia) semanas después de la última dosis.
    E.5.2Secondary end point(s)
    - PK parameters
    - Anti-Drug Antibody (ADA) response
    - Anti-tumor activity, i.e., reduction in tumor size according to RECIST
    1.1:
    - Objective Response Rate (ORR)
    - Disease Control Rate (DCR)
    - Duration of Response (DoR)
    • Parámetros de FC
    • Anticuerpos contra el fármaco [ACF]
    • Actividad antineoplásica; es decir, disminución del tamaño del tumor de conformidad con los criterios de evaluación de respuesta en tumores sólidos (RECIST) 1.1:
    o Tasa de respuesta objetiva (TRO)
    o Tasa de control de la enfermedad (TCE)
    o Duración de la respuesta (DdR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the entire study
    durante todo el estudio
    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 No
    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 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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Denmark
    Germany
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 trial is considered completed when the last subject dies or
    withdraws from the trial.
    However, maximal trial duration is 3 years after the last subject's first
    treatment.
    El ensayo se considera completado cuando el último sujeto muere o se retira del ensayo.
    Sin embargo, la duración máxima del ensayo es de 3 años después del primer tratamiento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 147
    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)
    Post trial treatment is at the discretion of the patient's doctor according to standard-of-care per country and site.
    The Sponsor will ensure post-trial treatment for ongoing trial participants with a potential treatment benefit of GEN1042.
    El tratamiento posterior al ensayo queda a discreción del médico del paciente de acuerdo con el estándar de atención por país y centro.
    El Sponsor garantizará el tratamiento posterior al ensayo para los participantes del ensayo en curso con un beneficio de tratamiento potencial de GEN1042.
    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 Decision2021-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-11
    P. End of Trial
    P.End of Trial StatusRestarted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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