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    Summary
    EudraCT Number:2021-006543-10
    Sponsor's Protocol Code Number:XB002-101
    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:2022-09-23
    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 number2021-006543-10
    A.3Full title of the trial
    A dose-escalation and expansion study of the safety and pharmacokinetics of XB002 as single-agent and combination therapy in subjects with inoperable locally advanced or metastatic solid tumors
    Estudio con aumento escalonado y ampliación de la dosis para evaluar la seguridad y la farmacocinética del XB002 en monoterapia y politerapia en pacientes con tumores sólidos localmente avanzados o metastásicos inoperables
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of XB002 in Subjects With Solid Tumors (JEWEL-101)
    Estudio de XB002 en sujetos con tumores sólidos (JEWEL-101)
    A.4.1Sponsor's protocol code numberXB002-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04925284
    A.5.4Other Identifiers
    Name:INDNumber:153,870
    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 SponsorExelixis, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportExelixis, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationExelixis, Inc.
    B.5.2Functional name of contact pointExelixis Medical Affairs
    B.5.3 Address:
    B.5.3.1Street Address1851 Harbor Bay Parkway
    B.5.3.2Town/ cityAlameda
    B.5.3.3Post codeCA 94502
    B.5.3.4CountryUnited States
    B.5.4Telephone number1888393 5494
    B.5.6E-maildruginfo@exelixis.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 nameXB002
    D.3.2Product code XB002
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for infusion (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNantibody-drug conjugate (ADC) XB002
    D.3.9.2Current sponsor codeXB002
    D.3.9.4EV Substance CodeSUB286399
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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.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 Yes
    D.2.1.1.1Trade name Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameNivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    Solution for injection (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNivolumab
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced solid tumors for whom life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. Single-agent XB002 will be evaluated up to 10 tumor types, and combination treatment will also be evaluated with nivolumab in NSCLC, SCCHN, and esophageal SCC.
    Tumores sólidos avanzados para los que no existen terapias que prolonguen la vida o las terapias disponibles son intolerables o ya no son eficaces. El agente único XB002 se evaluará hasta en 10 tipos de tumores, y también se evaluará el tratamiento combinado con nivolumab en el CPNM, el SCCHN y el CCE de esófago.
    E.1.1.1Medical condition in easily understood language
    SUBJECTS WITH INOPERABLE LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
    SUJETOS CON TUMORES SÓLIDOS LOCALMENTE AVANZADOS O METASTÁSICOS INOPERABLES
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083234
    E.1.2Term Hormone receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064467
    E.1.2Term Urothelial carcinoma
    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 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 LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical 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 10041823
    E.1.2Term Squamous cell carcinoma
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10030151
    E.1.2Term Oesophageal 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 10036909
    E.1.2Term Prostate cancer metastatic
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084066
    E.1.2Term Triple negative breast cancer metastatic
    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
    Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts): Primary:
    • To evaluate the preliminary efficacy of XB002 when administered alone and in combination therapy by estimating the ORR per RECIST 1.1 as assessed by the Investigator
    Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts): Primary:
    • To evaluate the preliminary efficacy of XB002 when administered alone and in combination therapy by estimating the ORR per RECIST 1.1 as assessed by the Investigator
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of XB002 when administered alone and in combination therapy
    • To further evaluate the PK of XB002 (antibody conjugated to payload), total antibody (unconjugated and conjugated antibody), and free payload following IV administration alone and in combination therapy
    • To assess the immunogenicity of XB002
    • To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by DOR and PFS per RECIST 1.1 as assessed by the Investigator
    • To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by ORR, DOR, and PFS per RECIST 1.1 as assessed by a Blinded Independent Radiology Committee (BIRC) for selected cohorts
    • To evaluate overall survival
    • To evaluate changes in tumor markers from baseline for selected tumor indications
    • Evaluar la seguridad y tolerabilidad del XB002 cuando se administra en monoterapia y politerapia.
    • Evaluar más en profundidad la FC del XB002 (anticuerpos conjugados con carga útil), los anticuerpos totales (anticuerpos conjugados y no conjugados) y la carga útil libre tras la administración i.v. en monoterapia y politerapia.
    • Evaluar la inmunogenicidad del XB002.
    • Evaluar la actividad antitumoral del XB002 en monoterapia y politerapia, medida mediante la DdR y la SSP de acuerdo con los criterios RECIST 1.1 evaluada por el investigador.
    • Evaluar la actividad antitumoral del XB002 en monoterapia y politerapia determinada mediante la TRO, la DdR y la SSP según los criterios RECIST 1.1 evaluada por un comité de radiología independiente con enmascaramiento (CRIE) en cohortes determinadas.
    • Evaluar la supervivencia global.
    • Evaluar los cambios en los marcadores tumorales con respecto al inicio en indicaciones tumorales seleccionadas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent.
    2. Subjects in the Cohort-Expansion Stage must have measurable disease per RECIST 1.1 as determined by the investigator. Note: Measurable disease is not required for subjects in the Dose-Escalation Stage.
    3. Available archival tumor tissue collected approximately 2 years prior to consent. If archival tumor tissue is not available, a fresh tumor biopsy may be collected from subjects enrolled in the Dose-Escalation Stage and must be collected from subjects in the Cohort-Expansion Stage, at least 7 days (and up to 60 days) prior to first dose. Specific requirements for tumor tissue samples are provided in the Laboratory Manual.
    4. Recovery to baseline or ≤ Grade 1 severity (Common Terminology Criteria for Adverse Events version 5 [CTCAE v5]) from AEs, unless AEs are clinically nonsignificant (eg, alopecia) or stable (eg, Grade 1 peripheral neuropathy).
    5. Age 18 years or older on the day of consent.
    6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
    7. Adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 10 days before first dose of study treatment:
    a. Absolute neutrophil count (ANC) ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor (G-CSF) support within 2 weeks prior to screening laboratory sample collection.
    b. Platelets ≥ 100,000/mm3 (≥ 100 GI/L)] without transfusion within 2 weeks prior to screening laboratory sample collection.
    c. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) without transfusion within 2 weeks prior to screening laboratory sample collection.
    d. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.2 × upper limit of normal (ULN) or International Normalized Ratio (INR) ≤ 1.3 without anticoagulation therapy (INR ≤ 3 if on stable oral coumarin-based anticoagulant).
    e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
    f. Total bilirubin ≤ 1.5 × ULN (for subjects with known Gilbert’s disease, total bilirubin ≤ 3 × ULN).
    g. Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 45 mL/min (≥ 0.75 mL/sec) using the Cockcroft-Gault equation
    8. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.
    9. Sexually active fertile subjects and their partners must agree to highly effective methods of contraception (defined in Appendix E) during the course of the study and for the following durations after the last dose of treatment (whichever is later):
    • 4 months after the last dose of XB002 for women of childbearing potential (WOCBP) and men, or
    • 5 months after the last dose of nivolumab for women
    An additional contraceptive method, such as a barrier method (eg, condom), is recommended.
    10. Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status
    1.Tumor sólido con confirmación citológica o bien histológica y radiológica, no operable, localmente avanzado, metastásico o recurrente.
    2.Los pacientes de la etapa de ampliación de cohortes deben tener enfermedad medible conforme a los criterios RECIST 1.1 según lo determine el investigador. Nota: no se requiere enfermedad medible en el caso de los pacientes de la etapa de aumento escalonado de la dosis
    3.Disponer de tejido tumoral de archivo recogido aproximadamente 2 años antes de la fecha de consentimiento. Si no se dispone de tejido tumoral de archivo, se podrá obtener una biopsia en fresco del tumor de los pacientes inscritos en la etapa de aumento escalonado de la dosis y de los pacientes de la etapa de ampliación de cohortes, al menos 7 días (y hasta 60 días) antes de la primera dosis. Los requisitos específicos de las muestras de tejido tumoral se indican en el Manual de laboratorio
    4.Recuperación de los AA a la intensidad inicial o grado ≤1 (criterios terminológicos comunes para acontecimientos adversos, versión 5 [CTCAE v5]), a menos que no sean clínicamente significativos (p. ej., alopecia) o sean estables (p. ej., neuropatía periférica de grado 1)
    5.Tener 18 años o más en la fecha de consentimiento.
    6.Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0-1.
    7.Función orgánica y medular suficiente, basada en el cumplimiento de la totalidad de los siguientes criterios analíticos en los 10 días previos a la primera dosis del tratamiento del estudio:
    a.Recuento absoluto de neutrófilos (RAN) ≥1500/mm3 (≥1,5 GI/l) sin terapia de apoyo con factor estimulante de colonias de granulocitos (G-CSF) en las 2 semanas previas a la recogida de la muestra de laboratorio en la selección.
    b.Plaquetas ≥100 000//mm3 (≥100 GI/l) sin transfusión en las 2 semanas previas a la recogida de la muestra de laboratorio en la selección.
    c.Hemoglobina ≥9 g/dl (≥90 g/l) sin transfusión en las 2 semanas previas a la recogida de la muestra de laboratorio en la selección.
    d.Tiempo de protrombina (TP) o tiempo de tromboplastina parcial activada (TTPa) ≤1,2 × límite superior de la normalidad (LSN) o índice internacional normalizado (INR, por sus siglas en inglés) ≤1,3 sin tratamiento anticoagulante (INR ≤3 para pacientes que reciban anticoagulantes orales con derivados de la cumarina).
    e.Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ≤ 3 × LSN.
    f.Bilirrubina total ≤1,5 × LSN (para pacientes con enfermedad de Gilbert conocida, bilirrubina total ≤3 × LSN).
    g.Creatinina sérica ≤1,5 × LSN o aclaramiento de creatinina calculado ≥45 ml/min (≥0,75 ml/s), según la fórmula de Cockcroft-Gault
    8.Capacidad para entender y cumplir los requisitos del protocolo; haber firmado el documento de consentimiento informado.
    9.Los pacientes fértiles sexualmente activos y sus parejas deben comprometerse a utilizar métodos anticonceptivos altamente eficaces (definidos en el apéndice E) durante el transcurso del estudio y durante los siguientes períodos después de la última dosis del tratamiento (lo que suceda más tarde):
    •cuatro meses después de la última dosis del XB002 para mujeres con capacidad de concebir (MCC) y hombres o;
    •cinco meses después de la última dosis de nivolumab en el caso de las mujeres.
    Se recomienda utilizar un método anticonceptivo adicional, como un método de barrera (p. ej., preservativo).
    10. Las pacientes con capacidad de concebir no deberán estar embarazadas en el momento de la selección. Se considera que las pacientes tienen capacidad de concebir a menos que cumplan uno de los siguientes criterios: esterilización permanente (histerectomía, salpingectomía bilateral u ovariectomía bilateral), o estado posmenopáusico documentado
    E.4Principal exclusion criteria
    Receipt of any tissue factor-targeting antibody drug conjugate or auristatin derivate based antibody drug conjugate.
    2. Receipt of any chemotherapy or anticancer antibody (eg, anti-VEGF mAb, antibody-drug conjugate, or PD-1/PD-L1 mAb) within 21 days (nitrosoureas or mitomycin within 42 days) before first dose of study treatment.
    3. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitors) within 2 weeks before first dose of study treatment.
    4. Receipt of any anticancer hormonal therapy within 2 weeks or within 5 half-lives of the agent, whichever is shorter, before first dose of study treatment. Note: Concomitant use of a luteinizing hormone-releasing hormone (LHRH) agonist (eg, leuprolide, goserelin) or antagonist (eg, relugolix) is permitted.
    5. Radiation therapy within 2 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications (eg, radiation induced esophagitis or pneumonitis) from prior radiation therapy are not eligible.
    6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment.
    7. The subject has uncontrolled, significant intercurrent or recent illness
    8. Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 4 weeks before first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction, biopsies) within 7 days before first dose. Complete wound healing from surgery must have occurred before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
    9. Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG) within 4 weeks before first dose of study treatment (see Section 5.6.6 for Fridericia formula).
    Note: If a single ECG shows a QTcF with an absolute value > 480 ms, two additional ECGs at intervals of approximately 3 minutes must be performed within 30 minutes after the initial ECG, and the average of the three consecutive results for QTcF must be ≤ 480 ms for the subject to be eligible.
    10. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
    11. Pregnant or lactating females.
    12. Previously identified allergy or hypersensitivity to components of the study treatment formulations or history of severe infusion-related reactions (IRRs) to monoclonal antibodies.
    13. Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
    1.Haber recibido cualquier conjugado de anticuerpo y fármaco dirigido al factor tisular o conjugado de anticuerpo y fármaco basado en un derivado de auristatina.
    2.Haber recibido cualquier quimioterapia o anticuerpo antineoplásico (p. ej., anticuerpo monoclonal anti-VEGF, conjugado de anticuerpo y fármaco, o anticuerpo monoclonal PD-1/PD-L1) en los 21 días (nitrosoureas o mitomicina en un plazo de 42 días) previos a la primera dosis del tratamiento del estudio.
    3.Haber recibido cualquier tipo de inhibidor de la cinasa de bajo peso molecular (incluidos inhibidores de la cinasa que estén en investigación) en las 2 semanas previas a la administración de la primera dosis del tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Cohort-Expansion Stage (Single-Agent and Combination Therapy Cohorts):
    To evaluate preliminary efficacy of XB002 when administered alone and in combination therapy by estimating the ORR per RECIST 1.1 as assessed by the Investigator
    Etapa de expansión de la cohorte (cohortes de agente único y de terapia combinada):
    Evaluar la eficacia preliminar de XB002 cuando se administra solo y en terapia combinada mediante la estimación de la ORR según RECIST 1.1 evaluada por el investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    The confirmation must have occurred on a subsequent visit that was ≥ 28 days after the response was first observed. Point estimates and 90% exact CIs for ORR will be evaluated independently within each of the dose escalation and expansion cohorts. Please refer to protocol.
    La confirmación debe haber ocurrido en una visita posterior que fuera ≥ 28 días después de que se observara la respuesta por primera vez. Las estimaciones puntuales y los IC exactos del 90% para la ORR se evaluarán de forma independiente dentro de cada una de las cohortes de escalada de dosis y de expansión. Consulte el protocolo.
    E.5.2Secondary end point(s)
    • To evaluate the safety and tolerability of XB002 when administered alone and in combination therapy
    • To further evaluate the PK of XB002 (antibody conjugated to payload), total antibody (unconjugated and conjugated antibody), and free payload following IV administration alone and in combination therapy
    • To assess the immunogenicity of XB002
    • To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by DOR and PFS per RECIST 1.1 as assessed by the Investigator
    • To evaluate the anti-tumor activity of XB002 alone and in combination therapy as measured by ORR, DOR, and PFS per RECIST 1.1 as assessed by a BIRC for selected cohorts
    • To evaluate overall survival
    • To evaluate changes in tumor markers from baseline for selected tumor indications
    • Evaluar la seguridad y tolerabilidad del XB002 cuando se administra en monoterapia y politerapia.
    • Evaluar más en profundidad la FC del XB002 (anticuerpos conjugados con carga útil), los anticuerpos totales (anticuerpos conjugados y no conjugados) y la carga útil libre tras la administración i.v. en monoterapia y politerapia.
    • Evaluar la inmunogenicidad del XB002.
    • Evaluar la actividad antitumoral del XB002 en monoterapia y politerapia, medida mediante la DdR y la SSP de acuerdo con los criterios RECIST 1.1 evaluada por el investigador.
    • Evaluar la actividad antitumoral del XB002 en monoterapia y politerapia determinada mediante la TRO, la DdR y la SSP según los criterios RECIST 1.1 evaluada por un comité de radiología independiente con enmascaramiento (CRIE) en cohortes determinadas.
    • Evaluar la supervivencia global.
    • Evaluar los cambios en los marcadores tumorales con respecto al inicio en indicaciones tumorales seleccionadas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol
    Consulte el protocolo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Analyses, Biomarker Analyses
    Análisis de inmunogenicidad, análisis de biomarcadores
    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 Yes
    E.8.1.7.1Other trial design description
    estudio de escalada de dosis y expansión
    dose-escalation and expansion study
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    United States
    France
    Netherlands
    Spain
    Germany
    Italy
    Belgium
    United Kingdom
    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 date of the last visit or procedure for the last subject remaining or the date at which the last data point required for follow-up for the last subject is obtained
    La fecha de la última visita o procedimiento para el último sujeto que queda o la fecha en la que se obtiene el último dato necesario para el seguimiento del último sujeto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 271
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 451
    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)
    Subjects may continue to receive study treatment for up to 12 months at the discretion of the Investigator and for an additional 12 months with the agreement of the Sponsor). Subjects may continue to receive XB002 for more than 24 months if the subject is deriving clear clinical benefit as determined by the Investigator and agreed by the Sponsor
    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 Opinion2022-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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