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    Summary
    EudraCT Number:2021-005481-18
    Sponsor's Protocol Code Number:BNT142-01
    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:2022-02-08
    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 number2021-005481-18
    A.3Full title of the trial
    First-in-human, open-label, multicenter, Phase I/IIa, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with CLDN6-positive advanced solid tumors
    Ensayo en fase I/IIa, primero en el ser humano, de aumento de la dosis, multicéntrico y sin enmascaramiento, con cohortes de prolongación, para evaluar la seguridad y la eficacia preliminar de BNT142 en pacientes con tumores sólidos avanzados con presencia de CLDN6
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and preliminary efficacy trial of BNT142 in patients with CLDN6 positive solid tumors
    Ensayo de la seguridad y la eficacia preliminar del BNT142 en pacientes con tumores sólidos con presencia de CLDN6
    A.4.1Sponsor's protocol code numberBNT142-01
    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 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 pointClinical Trials Information
    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+4961319084 - 0
    B.5.5Fax number+4961319084 - 0
    B.5.6E-mailLeticia.DeMattos@biontech.de
    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 nameBNT142
    D.3.2Product code BNT142
    D.3.4Pharmaceutical form Dispersion 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 applicable
    D.3.9.2Current sponsor codeRB_RMAB02.1 (mix of RBP021.1 and RBP022.1)
    D.3.9.3Other descriptive nameBNT142
    D.3.9.4EV Substance CodeSUB236110
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.08 to 1.32
    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) 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
    Claudin 6 (CLDN6)-positive advanced solid tumors
    Tumores sólidos avanzados con presencia de claudina 6 (CLDN6)
    E.1.1.1Medical condition in easily understood language
    A specific sub-type of cancers that presents in the form of solid tumors
    Un tipo específico de cánceres que se presentan en forma de tumores sólidos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10043302
    E.1.2Term Testicular 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 10033128
    E.1.2Term Ovarian 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 PT
    E.1.2Classification code 10061873
    E.1.2Term 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 21.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial 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 10007460
    E.1.2Term Carcinoma of unknown primary
    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 10065143
    E.1.2Term Malignant solid tumour
    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
    Parts 1 and 2: To assess the safety and tolerability of BNT142 at all dose levels tested.

    Part 1: To identify the maximum administered dose/maximum tolerated dose/recommended Phase II dose (MAD/MTD/RP2D) of BNT142 based on the occurrence of dose-limiting toxicities (DLTs) using the following definitions:
    • The MTD is defined as the highest tolerated dose where less than 1/3 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, PK and PD data from all dose levels tested.

    Part 2: To evaluate the anti-tumor activity of BNT142 according to RECIST 1.1 and for ovarian cancer patients according to definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and cancer antigen 125 (CA 125) agreed by the Gynecological Cancer Intergroup (GCIG).
    En las partes 1 y 2: Evaluar la seguridad y la tolerabilidad del BNT142 en todos los niveles de dosis probados.

    En la parte 1: identificar la dosis máxima administrada o la dosis máxima tolerada (DMA/DMT) y la dosis recomendada en la fase II (DRF2) de BNT142 según la incidencia de toxicidades limitantes de la dosis (TLD) con las siguientes definiciones:
    • La DMT se define como la dosis más alta tolerada en la que menos de 1/3 de los pacientes sufrió una TLD. La DMA se define como la dosis más alta administrada en la que se toleraron todos los niveles durante el aumento de la dosis.
    • La DRF2 se definirá según la evaluación integrada de los datos de seguridad, tolerabilidad, beneficio clínico, farmacocinética (FC) y farmacodinámica (FD) de todos los niveles de dosis probados.

    Para obtener una lista completa de objetivos, consulte la sección 1.1 del protocolo.
    E.2.2Secondary objectives of the trial
    Parts 1 and 2: To characterize the PK profile of the BNT142-encoded protein RiboMab02.1.

    Parts 1 and 2: To evaluate the anti-tumor activity of BNT142 according to RECIST 1.1, and for ovarian cancer patients according to definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and cancer antigen 125 (CA 125) agreed by the Gynecological Cancer Intergroup (GCIG).

    Parts 1 and 2: To evaluate the immunogenicity of BNT142
    En las partes 1 y 2: Caracterizar el perfil FC de la proteína RiboMab02.1 codificada en el BNT142.

    En las partes 1 y 2: evaluar la actividad antitumoral del BNT142 según RECIST 1.1 y en pacientes con cáncer de ovario según las definiciones de remisión y progresión en ensayos clínicos para el cáncer de ovario que incorporan RECIST 1.1 y el antígeno del cáncer 125 (CA 125) acordado por el Gynecological Cancer Intergroup (GCIG).

    En las partes 1 y 2: evaluar la inmunogenia del BNT142.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For both parts:
    • Histological or cytological documentation of a solid tumor that is metastatic or unresectable via a pathology report.
    • CLDN6-positive tumor sample as assessed by central testing using a validated IHC assay in formalin-fixed paraffin-embedded (FFPE) neoplastic tissues. FFPE tissue can be derived from fresh biopsies and archival samples. If archival tissue samples from several points of time are available, the most recent one is preferred.
    • Measurable disease per RECIST 1.1 (measurable per RECIST 1.1 or evaluable per GCIG criteria for ovarian tumors).

    For Part 1 (Dose escalation):
    • Patients with advanced/metastatic ovarian, non-squamous NSCLC, endometrial, or testicular cancer, for whom there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy, or patients with NOS tumors not included in the eligible tumor types, including rare tumors and cancers of unknown primary, upon approval by the medical monitor. Patients must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the FDA, ASCO, ESMO or local guidelines used at the site), and failed at least first line SOC therapy prior to enrollment.

    For Part 2 (Expansion):
    • Expansion Cohort 1: CLDN6-positive ovarian cancer patients who have received at least one systemic treatment regimen for advanced/metastatic disease with radiographic disease progression on or after last prior treatment and who are not eligible for SOC therapy at the discretion of the investigator.
    • Expansion Cohort 2: CLDN6-positive non-squamous NSCLC who have received at least one prior systemic treatment regimen for advanced/metastatic disease with radiographic disease progression on or after last prior treatment and who are not eligible for SOC therapy at the discretion of the investigator.
    • Expansion Cohort 3: CLDN6-positive testicular cancer patients who have received at least one systemic treatment regimen for advanced/metastatic disease with radiographic disease progression on or after last prior treatment and who are not eligible for SOC therapy at the discretion of the investigator.
    Note: Patients are considered as not eligible for SOC therapy if in the opinion of the investigator, e.g., there is no effective SOC therapy available, SOC is contraindicated or patient has refused SOC treatment.
    En ambas partes:
    • Documentación histológica o citológica (mediante informe anatomopatológico) de un tumor sólido metastásico o irresecable.
    • Muestra tumoral con presencia de CLDN6 evaluada mediante pruebas centrales con un ensayo validado de IHQ en tejidos neoplásicos fijados con formol e incluidos en parafina (FFIP). El tejido FFIP puede derivarse de biopsias en fresco y muestras de archivo. Si se dispone de muestras de tejido de archivo de varios puntos temporales, se escogerá la más reciente.
    • Enfermedad cuantificable según RECIST 1.1 (cuantificable según RECIST 1.1 o que se pueda evaluar según los criterios del GCIG para tumores de ovario).

    En la parte 1 (aumento de la dosis):
    • Pacientes con cáncer de ovario avanzado/metastásico, CPNM de tipo no escamoso, cáncer endometrial o testicular para quienes no hay ningún tratamiento de referencia que pueda ofrecerles un beneficio clínico, o no pueden recibirlo, o pacientes con tumores no especificados que no estén incluidos en los tumores que cumplen los requisitos, como algunos tumores raros y neoplasias de origen primario desconocido, con la aprobación del monitor médico. Los pacientes deben haber recibido todos los tratamientos de referencia disponibles, incluidos los tratamientos dirigidos en base al estado de la mutación (según las directrices de la FDA, ASCO, ESMO o las pautas locales que se utilicen en el centro), y no haber obtenido remisión con al menos la primera línea del tratamiento de referencia antes de la inclusión.

    En la parte 2 (prolongación):
    • Cohorte de prolongación 1: pacientes con cáncer de ovario con presencia de CLDN6 que han recibido al menos una pauta terapéutica sistémica para tratar la enfermedad avanzada o metastásica con progresión de la enfermedad radiográfica durante o después del último tratamiento anterior y que no son aptos para recibir el tratamiento de referencia a discreción del investigador.
    • Cohorte de prolongación 2: pacientes con CPNM de tipo no escamoso con presencia de CLDN6 que han recibido al menos una pauta terapéutica sistémica anterior para tratar la enfermedad avanzada o metastásica con progresión de la enfermedad radiográfica durante o después del último tratamiento anterior y que no son aptos para recibir el tratamiento de referencia a discreción del investigador.
    • Cohorte de prolongación 3: pacientes con cáncer testicular con presencia de CLDN6 que han recibido al menos una pauta terapéutica sistémica para tratar la enfermedad avanzada o metastásica con progresión de la enfermedad radiográfica durante o después del último tratamiento anterior y que no son aptos para recibir el tratamiento de referencia a discreción del investigador.

    Nota: Se considera que los pacientes no son aptos para recibir el tratamiento de referencia si, en opinión del investigador, p. ej., no se dispone de un tratamiento de referencia eficaz, el tratamiento de referencia está contraindicado o el paciente lo ha rechazado.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will not be eligible for trial entry:
    • 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; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.
    • Concurrent systemic (oral or intravenous [IV]) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition apart from physiologic corticosteroid replacement therapy.
    • Major surgery within 4 weeks before the first dose of BNT142.
    • 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 BNT142.
    • Prior treatment with a CLDN6 targeting monoclonal antibody.
    • Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5 Grade ≤1, 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. Alopecia of any grade is allowed.
    • Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain metastases may be eligible if they:
    − Had radiotherapy, surgery or stereotactic surgery for the brain metastases;
    − Have no neurological symptoms (excluding Grade ≤2 neuropathy);
    − Have stable brain metastasis on the computer tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent form (ICF); and
    − Are not undergoing acute corticosteroid therapy or steroid taper.
    Notes: Patients with central nervous system (CNS) symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal bone metastases are allowed, unless imminent fracture with cord compression is anticipated.
    • Pregnant or breastfeeding or planning to get pregnant within 6 months of the last dose of BNT142.
    Los pacientes que cumplan alguno de los siguientes criterios de exclusión no podrán participar en el ensayo:
    • Radioterapia, quimioterapia o fármacos dirigidos a moléculas en las 3 semanas o 5 semividas (lo que sea más largo) anteriores al inicio del tratamiento del ensayo; inmunoterapia o anticuerpos monoclonales en las 3 semanas anteriores al inicio del tratamiento del ensayo; nitrosoureas, conjugados de anticuerpo y fármaco, o isótopos radiactivos en las 6 semanas anteriores al inicio del tratamiento del ensayo.
    • Tratamiento con esteroides sistémicos simultáneos (por vía oral o intravenosa [i.v.]), es decir, >10 mg de prednisona al día o su equivalente para una afección subyacente, además del tratamiento sustitutivo de corticoesteroides fisiológicos.
    • Cirugía mayor en las 4 semanas anteriores a la primera dosis de BNT142.
    • Infección persistente o activa que requiere tratamiento i.v. con terapia antiinfecciosa que se ha administrado menos de 2 semanas antes de la primera dosis de BNT142.
    • Tratamiento anterior con un anticuerpo monoclonal dirigido a CLDN6.
    • Efectos secundarios de cualquier tratamiento o procedimiento anterior para cualquier dolencia que no se hayan resuelto a un grado ≤1 según la v.5 de los Criterios Comunes de Terminología para Acontecimientos Adversos (CTCAE) del National Cancer Institute (NCI), a excepción de alopecia, anorexia, vitíligo, fatiga, hipertiroidismo, hipotiroidismo y neuropatía periférica. La anorexia, el hipertiroidismo, el hipotiroidismo y la neuropatía periférica se tienen que haber recuperado hasta un grado ≤2. Se permite la alopecia de cualquier grado.
    • Indicios actuales de metástasis leptomeníngeas o cerebrales nuevas o en crecimiento durante la selección. Los pacientes con metástasis cerebrales conocidas pueden participar si:
    − se han sometido a radioterapia, cirugía o cirugía estereotáctica para las metástasis cerebrales;
    − no presentan síntomas neurológicos (excluida la neuropatía de grado ≤2);
    − tienen metástasis cerebral estable en la tomografía computarizada (TC) o la resonancia magnética (RM) en las 4 semanas anteriores a la firma del documento de consentimiento informado (DCI); y
    − no se someten a tratamiento agudo con corticoesteroides ni a una disminución progresiva de esteroides.

    Notas: Los pacientes con síntomas del sistema nervioso central (SNC) deben someterse a una TC o una RM del cerebro para descartar metástasis cerebrales nuevas o progresivas. Se permiten las metástasis en la columna vertebral, a menos que se prevea una fractura inminente con compresión medular.

    • La paciente está embarazada o amamantando, o planea quedarse embarazada en los 6 meses posteriores a la última dosis de BNT142.
    E.5 End points
    E.5.1Primary end point(s)
    Parts 1 and 2:
    • Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to trial treatment.
    • Occurrence of dose reductions and discontinuation of BNT142 due to TEAEs.

    Part 1:
    • Occurrence of DLTs during the DLT evaluation period (Cycle 1, i.e., 21 days after the first dose) during the dose escalation.

    Part 2:
    • 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, and per GCIG criteria incorporating RECIST 1.1 and CA 125 for the ovarian cancer population is the best overall response
    En las partes 1 y 2:
    • Aparición de acontecimientos adversos surgidos durante el tratamiento (AAST), incluidos los AAST de grado ≥3, graves o mortales por relación causal con el tratamiento del ensayo.
    • Acontecimientos de reducciones de dosis e interrupciones del BNT142 debido a AAST.

    En la parte 1:
    • Incidencia de TLD durante el periodo de evaluación de TLD (ciclo 1, o sea, 21 días después de la primera dosis) durante el aumento de la dosis.

    En la parte 2:
    • El índice de respuesta objetiva (IRO) se define como la proporción de pacientes en los que la remisión completa (RC) o la respuesta parcial (RP), según RECIST 1.1 y los criterios del GCIG que incorporan RECIST 1.1 y CA 125 para la población con cáncer de ovario, es la mejor respuesta global.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the DLT evaluation period (refer to the protocol for further details)
    Durante el periodo de evaluación de la TLD (en el protocolo hay más información)
    E.5.2Secondary end point(s)
    Parts 1 and 2:
    • PK parameters including but not limited to AUC, CL and Vd, Cmax, tmax, Ctrough, Cmin, and t½.
    • ORR (Part 1 only; this is a primary endpoint for Part 2) is defined as the proportion of patients in whom a CR or PR, per RECIST 1.1, is the 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 [and per GCIG criteria for ovarian cancer patients], SD assessed at least 6 weeks after first dose) 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.
    • Anti-drug antibodies (ADAs) response assessed with BNT142-encoded protein anti-RiboMab02.1, and anti-polyethylene glycol (PEG) lipid antibodies.
    En las partes 1 y 2:
    • Parámetros FC como, entre otros, ABC, aclaramiento y volumen de distribución, Cmáx, tmáx, Ctrough, Cmín, y t½.
    • El IRO (solo en la parte 1; se trata de un criterio de valoración principal de la parte 2) se define como la proporción de pacientes en los que la mejor respuesta global es la RC o la RP, según RECIST 1.1.
    • La tasa de control de la enfermedad (TCE) se define como la proporción de pacientes en los que la mejor respuesta global es la RC, la RP o la enfermedad estable ([EE], según RECIST 1.1 [y los criterios del GCIG para pacientes con cáncer de ovario], EE evaluada al menos 6 semanas después de la primera dosis).
    • La duración de la remisión (DdR) se define como el tiempo transcurrido desde la primera remisión objetiva (RC o RP según RECIST 1.1) hasta la primera aparición de progresión objetiva del tumor (progresión de la enfermedad según RECIST 1.1) o la muerte por cualquier causa, lo que ocurra primero.
    • Respuesta de los anticuerpos antifármaco (AAF) evaluada con la proteína anti-RiboMab02.1 codificada en BNT142 y los anticuerpos lipídicos antipolietilenglicol (PEG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the treatment phase and primary follow up period (refer to the schedule of trial procedures in the protocol for further details).
    Durante la fase de tratamiento y el periodo de seguimiento principal (en el calendario de procedimientos del ensayo del protocolo hay más información).
    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, immunogenicity, biomarkers (exploratory PD, exploratory predictive, tumour), genetics (potential retrospective analysis)
    Tolerabilidad, imnunogenicidad, biomarcadores (FD exploratoria, predictivos exploratorios y tumorales), genética (posible análisis retrospectivo)
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Spain
    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 the trial is defined as when:
    - All patients have discontinued BNT142 treatment; and
    - All patients have completed safety follow-up assessment at Day 60 subsequent to last dose; and
    - All patients have been followed-up for at least 48 months subsequent to first dose, are lost to follow-up, or have died.

    OR

    - The sponsor discontinues the trial.
    Se define como finalización del ensayo el momento en que:
    - Todos los pacientes han suspendido el tratamiento con BNT142; y
    - Todos los pacientes han finalizado la evaluación de seguimiento de la seguridad del día 60 tras la última dosis; y
    - Todos los pacientes han tenido un seguimiento de al menos 48 meses tras
    la primera dosis, se ha perdido el contacto con ellos durante el seguimiento o han fallecido.

    O BIEN

    - El promotor suspende el ensayo.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 98
    F.4.2.2In the whole clinical trial 216
    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)
    Currently no treatment with the IMP is planned after the End of Trial. Following the second safety follow-up visit, site staff will make contact with the patient every 12 weeks until the patient is lost to follow-up or dies to determine survival status and if they have taken any new anti-cancer treatments.
    Actualmente, no se prevé que haya tratamiento con el PEI tras la finalización del ensayo. Tras la segunda visita de seguimiento de la seguridad, el personal del centro contactará con los pacientes cada 12 semanas hasta que se pierda el contacto con ellos durante el seguimiento o fallezcan. Dicho seguimiento se realizará para determinar si siguen vivos y si han tomado algún nuevo tratamiento oncológico.
    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 Decision2022-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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