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    Summary
    EudraCT Number:2022-001843-25
    Sponsor's Protocol Code Number:BNT141-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2023-01-20
    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 number2022-001843-25
    A.3Full title of the trial
    Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT141 as a monotherapy and in combination with other anti-cancer agents in patients with CLDN18.2-positive solid tumors
    Primer ensayo en humanos de fase I/IIa, abierto, de aumento escalonado de la dosis, con cohortes de expansión para evaluar la seguridad, la farmacocinética, la farmacodinámica y la eficacia preliminar de BNT141 como monoterapia y en combinación con otros agentes contra el cáncer en pacientes con tumores sólidos positivos para CLDN18.2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global study to evaluate preliminary efficacy of cancer drug BNT141 in patients with unresectable or metastatic CLDN18.2-positive solid tumors
    Un estudio global para evaluar la eficacia preliminar del fármaco contra el cáncer BNT141 en pacientes con tumores sólidos CLDN18.2 positivos irresecables o metastásicos
    A.3.2Name or abbreviated title of the trial where available
    Safety and preliminary efficacy trial of BNT141 in patients with CLDN18.2-positive solid tumors
    Ensayo preliminar de seguridad y eficacia de BNT141 en pacientes con tumores positivos positivos par
    A.4.1Sponsor's protocol code numberBNT141-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04683939
    A.5.4Other Identifiers
    Name:IND numberNumber:27153
    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 SponsorBioNTech SE
    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 supportBioNTech SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioNTech SE
    B.5.2Functional name of contact pointJulia Dauer
    B.5.3 Address:
    B.5.3.1Street AddressAn der Goldgrube 12
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+1617337-4701
    B.5.6E-mailjulia.dauer@biontech.us
    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 nameBNT141
    D.3.2Product code RB_RMAB01.1 (mix of RBP015.1 and RBP016.1)
    D.3.4Pharmaceutical form Concentrate for suspension for injection
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRBP015.1
    D.3.9.3Other descriptive nameRB_RMAB01.1
    D.3.9.4EV Substance CodeSUB298418
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeRBP016.1
    D.3.9.3Other descriptive nameRB_RMAB01.1
    D.3.9.4EV Substance CodeSUB298418
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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) Yes
    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
    CLDN18.2-positive solid tumors
    Tumores sólidos CLDN18.2 positivos
    E.1.1.1Medical condition in easily understood language
    CLDN18.2-positive solid tumors
    Tumores sólidos CLDN18.2 positivos
    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 10065252
    E.1.2Term Solid tumor
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    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 10015332
    E.1.2Term Esophageal adenocarcinoma recurrent
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004676
    E.1.2Term Biliary tract disease
    E.1.2System Organ Class 100000004871
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008593
    E.1.2Term Cholangiocarcinoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric 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
    To assess the safety and tolerability of BNT141 at different dose levels

    To identify the maximum tolerated dose (MTD) or maximally administered dose (MAD) /recommended Phase II dose (RP2D) of BNT141 based on the occurrence of dose-limiting toxicities (DLTs) using the following definitions:
    • The MTD will be defined as the highest tolerated dose, where less than one-third of the patients experience a DLT.
    • The MAD is defined as the highest dose administered, where all dose levels were tolerated during dose escalation.
    • The RP2D will be defined based on integrated evaluation of safety, tolerability, clinical benefit, pharmacokinetic (PK), and pharmacodynamic (PD) data, for all dose levels tested.
    Evaluar la seguridad y la tolerabilidad de BNT141 a distintos niveles de dosis.
    Identificar la dosis máxima tolerada (DMT) o la dosis máxima administrada (DMA)/dosis recomendada para la fase II (DRFII) de BNT141 en función de la aparición de toxicidades limitantes de la dosis (TLD) conforme a las siguientes definiciones:
    • La DMT se definirá como la dosis más alta tolerada con la que menos de un tercio de los pacientes experimenta una TLD.
    • La DMA se define como la dosis más alta administrada, habiéndose tolerado todos los niveles de dosis durante el aumento escalonado de la dosis.
    • La DRFII se definirá a partir de la evaluación integrada de los datos de seguridad, tolerabilidad, beneficio clínico, farmacocinética (FC) y farmacodinámica (FD) de todos los niveles de dosis probados.
    E.2.2Secondary objectives of the trial
    To characterize the PK profile of the BNT141-encoded protein RiboMab01.

    To evaluate the anti-tumor activity of BNT141 according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    Caracterizar el perfil farmacocinético de la proteína RiboMab01 codificada en BNT141.

    Evaluar la actividad antitumoral de BNT141 según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all parts:
    • Metastatic or unresectable solid tumor.
    • Histological or cytological documentation of a solid tumor via a pathology report.
    • CLDN18.2-positive tumor sample defined as moderate-to-strong CLDN18.2 protein expression defined as intermediate (2+) to strong (3+) staining intensity in ≥ 50% of tumor cells as assessed by central testing using a CLIA-validated immunohistochemistry assay in formalin-fixed, paraffin-embedded (FFPE) neoplastic tissues. New biopsies and archival bio-samples are allowed. Bone biopsies are not allowed. Cytology specimens (including fine needle aspirates) will not be accepted for CLDN18.2 examination. If archival tissue samples from several points of time are available, the most recent one is preferred. Patients with a lower expression level or with CLDN18.2-negative cancers are not eligible.

    Trial part-specific inclusion criteria:

    • For Part 1A: Patients with solid tumors, for which there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy. Patients must have received all available standard therapies and failed at least first-line SOC therapy prior to enrolment. Measurable or evaluable disease per RECIST 1.1. Eligible tumor types are gastric cancer, gastroesophageal junction (GEJ) and esophageal adenocarcinoma, pancreatic, biliary tract (cholangiocarcinoma and gallbladder cancer), and mucinous ovarian cancers.
    Additionally, patients with specific tumors (including colorectal cancer, non-small cell lung cancer, gastric subtype of endocervical adenocarcinoma) where there is scientific evidence that the CLDN18.2 could be elevated can be tested for CLDN18.2 expression.
    • For Part 1B: Patients with advanced pancreatic adenocarcinoma or cholangiocarcinoma who are eligible for treatment with nab-paclitaxel and gemcitabine. Measurable or evaluable disease per RECIST 1.1.

    • For Part 2 (Expansion):
    − Cohort 1 – Pancreatic adenocarcinoma: pancreatic adenocarcinoma eligible for treatment with nab-paclitaxel and gemcitabine. Measurable disease per RECIST 1.1.
    − Cohort 2 – Cholangiocarcinoma: cholangiocarcinoma eligible for treatment with nab-paclitaxel and gemcitabine. Measurable disease per RECIST 1.1.

    For complete list of inclusion criteria, please refer to the protocol.
    Para todas las partes:
    • Tumor sólido metastásico o irresecable.
    • Documentación histológica o citológica de un tumor sólido mediante informe patológico.
    • Muestra tumoral positiva para CLDN18.2, definida como una expresión de moderada a fuerte de la proteína CLDN18.2, lo que se define como una intensidad de coloración de intermedia (superior a 2) a fuerte (superior a 3) en ≥ 50 % de las células tumorales, evaluada en pruebas centrales mediante un ensayo inmunohistoquímico validado para CLIA en tejidos neoplásicos fijados con formol y embebidos en parafina (FFEP). Están permitidas las biopsias nuevas y las muestras biológicas de archivo. Las biopsias óseas no están permitidas. No se aceptarán muestras de citología (incluidos los aspirados con aguja fina) para el examen de CLDN18.2. Si se dispone de muestras de tejido de archivo de varios puntos temporales, se utilizará preferiblemente la más reciente. Los pacientes con un nivel de expresión inferior o con cánceres negativos para CLDN18.2 no son elegibles.
    Criterios de inclusión específicos de cada parte del ensayo:
    • Para la parte 1A: Pacientes con tumores sólidos para los que no haya disponible un tratamiento estándar que pueda conferir un beneficio clínico, o pacientes que no reúnan los criterios para recibir dicho tratamiento. Los pacientes deben haber
    recibido todos los tratamientos estándar disponibles y haber fracasado al menos con el TE de primera línea antes de la inclusión. Enfermedad medible o evaluable según los criterios RECIST 1.1 Los tipos de tumores considerables son el cáncer gástrico, el adenocarcinoma de unión gastroesofágica (UGE) y esófago, el cáncer de páncreas, el cáncer de vías biliares (colangiocarcinoma y cáncer de vesícula biliar) y el cáncer mucinoso de ovario. Además, los pacientes con determinados tumores (incluidos el cáncer colorrectal, el cáncer de pulmón no microcítico y el subtipo gástrico del adenocarcinoma endocervical) que presenten evidencia científica de que la CLDN18.2 podría encontrarse en niveles elevados podrían someterse a análisis de la expresión de CLDN18.2. • Para la parte 1B: Pacientes con adenocarcinoma de páncreas o colangiocarcinoma avanzados que reúnan los criterios para el tratamiento con nab-paclitaxel y gemcitabina. Enfermedad medible o evaluable según los criterios RECIST 1.1.
    • Parte 2 (expansión):
    − Cohorte 1, adenocarcinoma de páncreas: adenocarcinoma de páncreas que reúna los criterios para el tratamiento con nab-paclitaxel y gemcitabina. Enfermedad medible según los criterios RECIST 1.1.
    − Cohorte 2, colangiocarcinoma: colangiocarcinoma que reúna los criterios para el tratamiento con nab-paclitaxel y gemcitabina. Enfermedad medible según los criterios RECIST 1.1.
    E.4Principal exclusion criteria
    • Receiving: radiotherapy, chemotherapy, or molecularly-targeted agents within 3 weeks or 5 half-lives (whichever is longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment
    (excluding BNT141); nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment. Palliative radiotherapy will be allowed.
    • Receives concurrent systemic (oral or intravenous [IV]) steroid therapy > 10 mg prednisone daily or its equivalent for an underlying condition.
    • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.
    • Major surgery within 4 weeks before the first dose of BNT141.
    • Prior treatment with a CLDN18.2 targeting mAb other than BNT141.
    • Ongoing or active infection requiring IV treatment with anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT141.
    • Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for AEs (NCICTCAE) v.5 Grade ≤ 1, with the exception of anorexia, fatigue, hyperthyroidism,
    hypothyroidism, and peripheral neuropathy, which must have recovered to ≤ Grade 2. Alopecia of any grade is allowed.
    • Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain or leptomeningeal metastases may be eligible if they have:
    − Radiotherapy, surgery or stereotactic surgery for the brain or leptomeningeal metastases.
    − No neurological symptoms (excluding Grade ≤ 2 neuropathy).
    − Stable brain or leptomeningeal disease on the computer tomography (CT) or magnet resonance imaging (MRI) scan within 4 weeks before signing the informed consent form (ICF).
    − Not undergoing acute corticosteroid therapy or steroid taper.

    For complete list of exclusion criteria, please refer to the protocol.
    • Que reciban: radioterapia, quimioterapia o agentes molecularmente dirigidos a menos de 3 semanas o 5 semividas (lo que sea más largo) del inicio del tratamiento del ensayo; inmunoterapia/anticuerpos monoclonales a menos de 3 semanas del inicio del tratamiento del ensayo (sin incluir BNT141); nitrosoureas, conjugados anticuerpo-fármaco o isótopos radiactivos a menos de 6 semanas del inicio del tratamiento del ensayo. Se permitirá la radioterapia paliativa.
    • Que reciban un tratamiento (oral o intravenoso [i.v.]) simultáneo con esteroides sistémicos de >10 mg de prednisona al día o su equivalente para una enfermedad subyacente.
    • El tratamiento de sustitución (por ejemplo, tiroxina, insulina o tratamiento de sustitución con corticosteroides fisiológicos para la insuficiencia suprarrenal o hipofisaria) no se considera una forma de tratamiento sistémico y está permitido.
    • Cirugía mayor en las 4 semanas previas a la primera dosis de BNT141.
    • Tratamiento previo con un anticuerpo monoclonal (Acm) dirigido a CLDN18.2 distinto de BNT141.
    • Infección en curso o activa que requiera tratamiento antiinfeccioso i.v. que se haya administrado menos de 2 semanas antes de la primera dosis de BNT141.
    • Efectos secundarios de cualquier tratamiento o procedimiento previo para cualquier afección médica que no se haya recuperado hasta un grado ≤1 según los Criterios Terminológicos Comunes para AA del Instituto Nacional del Cáncer (NCI-CTCAE), versión 5, a excepción de anorexia, fatiga, hipertiroidismo, hipotiroidismo y neuropatía periférica, que deben haberse recuperado hasta un grado ≤2. Se permite la alopecia de cualquier grado.
    • Indicios de metástasis leptomeníngeas o cerebrales de aparición reciente o progresivas durante la selección. Los pacientes con metástasis leptomeníngeas o cerebrales conocidas podrán ser considerables en caso de:
    − Radioterapia, cirugía o cirugía estereotáctica para las metástasis cerebrales o leptomeníngeas.
    − Ausencia de síntomas neurológicos (salvo neuropatía de grado ≤2).
    − Enfermedad cerebral o leptomeníngea estable confirmada mediante tomografía axial computarizada (TAC) o resonancia magnética (RM) en las 4 semanas anteriores a la firma del formulario de consentimiento informado (FCI).
    − No recibir ningún tratamiento agudo con corticoesteroides ni estar sometidos a la disminución progresiva de un tratamiento con corticoesteroides.
    Para obtener una lista completa de los criterios de exclusión, consulte el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    * Occurrence of treatment-emergent adverse events (TEAEs) within a patient including Grade ≥ 3, serious, fatal TEAE by relationship.
    * Occurrence of dose reductions and discontinuation of BNT141 due to TEAEs.
    * Occurrence of DLTs within a patient during the DLT evaluation period.
    *Aparición de acontecimientos adversos surgidos durante el tratamiento (AAST) en un paciente, incluidos los AAST de grado ≥3, graves y mortales según su relación con el tratamiento.
    *Reducciones de dosis y discontinuación del tratamiento con BNT141 debido a AAST.
    *Aparición de TLD en un paciente durante el periodo de evaluación de la TLD.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer to protocol for timepoints of evaluation
    Consulte el protocolo para conocer los puntos de tiempo de la evaluación.
    E.5.2Secondary end point(s)
    * PK parameters including but not limited to area-under-theconcentration-time curve (AUC), clearance (CL), volume of distribution (Vd), maximum concentration (Cmax), time to Cmax (tmax)measured concentration at the end of a dosing interval [taken directly before next administration] (Ctrough), and half-life (t½).
    * Objective response rate (ORR) is defined as the proportion of patients in whom a complete response (CR) or partial response ([PR], per RECIST 1.1) is confirmed as best overall response.
    * Disease control rate (DCR) is defined as the proportion of patients in whom a CR or PR or stable disease ([SD], per
    RECIST 1.1, SD assessed at least 6 weeks after first dose) is observed as best overall response.
    * Duration of response (DOR) is defined as the time from first objective response (CR or PR per RECIST 1.1) to first
    occurrence of objective tumor progression (progressive disease per RECIST 1.1) or death from any cause, whichever occurs first.
    • Los parámetros farmacocinéticos incluyen, entre otros, el área bajo la curva (ABC) de concentración y tiempo, el aclaramiento (CL), el volumen de distribución (Vd), la concentración máxima (Cmáx.), el tiempo para alcanzar la Cmáx. (tmáx.), la concentración medida al final de un intervalo de administración de dosis [justo antes de la siguiente administración] (Cmín.) y la semivida (t½).
    •La tasa de respuesta objetiva (TRO) se define como la proporción de pacientes en los que se confirman una respuesta completa (RC) o respuesta parcial (RP) (según los criterios RECIST 1.1) como la mejor respuesta global.
    •La tasa de control de la enfermedad (TCE) se define como la proporción de pacientes en los que se observan una RC, una RP o enfermedad estable (EE) (según los criterios RECIST 1.1, evaluados como mínimo 6 semanas después de la primera dosis) como mejor respuesta global.
    • La duración de la respuesta (DdR) se define como el tiempo transcurrido desde la primera respuesta objetiva (RC o RP según los criterios RECIST 1.1) hasta la primera aparición de progresión tumoral objetiva (progresión de la enfermedad según los criterios RECIST 1.1) o hasta la
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to protocol for timepoints of evaluation
    Consulte el protocolo para conocer los puntos de tiempo de la evaluación.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarker Analysis, Immunogenicity
    Tolerabilidad, análisis de biomarcadores, inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diferente dosis del mismo producto
    Different dose of the same product
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    United States
    Netherlands
    Spain
    Germany
    Denmark
    Portugal
    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
    The trial is considered completed when all patients:
    * have had at least 12 months survival follow up OR
    * are lost to follow up OR
    * have withdrawn consent OR
    * have died OR
    * the sponsor discontinues the trial.
    El ensayo se considera completado cuando todos los pacientes:
    * han tenido al menos 12 meses de seguimiento de supervivencia O
    * se pierden durante el seguimiento O
    * haber retirado el consentimiento O
    * han muerto O
    * el patrocinador interrumpe el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days14
    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: 54
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 154
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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