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    Summary
    EudraCT Number:2019-000104-15
    Sponsor's Protocol Code Number:CCS1477-02
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 number2019-000104-15
    A.3Full title of the trial
    An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy in patients with advanced haematological malignancies.
    Estudio abierto de fase I/IIa para evaluar la seguridad y eficacia de
    CCS1477
    en monoterapia en pacientes con neoplasias hematológicas avanzadas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first time in man study to look at the safety of the experimental drug CCS1477 and what effects it has on cancers that affect the blood, bone marrow, lymph and lymphatic system.
    Primer estudio en humanos para analizar la seguridad del fármaco
    experimental CCS1477 y los efectos que tiene sobre los cánceres que
    afectan la sangre, la médula ósea, la linfa y el sistema linfático.
    A.3.2Name or abbreviated title of the trial where available
    Phase I/IIa study to evaluate CCS1477 in haem. malignancies
    Estudio de fase I/IIa para evaluar CCS1477 en malignidades hematológicas
    A.4.1Sponsor's protocol code numberCCS1477-02
    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 SponsorCellCentric Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportCellCentric Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCellCentric Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChesterford Research Park
    B.5.3.2Town/ cityLittle Chesterford
    B.5.3.3Post codeCB10 1XL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01799531130
    B.5.5Fax number01799531099
    B.5.6E-mailwill.west@cellcentric.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.3.2Product code CCS1477 10 mg
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-M
    D.3.9.3Other descriptive nameInhibitor of the bromodomain of p300 & CBP
    D.3.9.4EV Substance CodeAS12
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-MB
    D.3.9.3Other descriptive nameCCS1477
    D.3.9.4EV Substance CodeAS13
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    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) 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 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.3.2Product code CCS1477 25 mg
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-M
    D.3.9.3Other descriptive nameInhibitor of the bromodomain of p300 & CBP
    D.3.9.4EV Substance CodeSUB193153
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-MB
    D.3.9.3Other descriptive nameCCS1477
    D.3.9.4EV Substance CodeSUB193153
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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
    Acute Myeloid Leukaemia (AML)/high-risk Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM) and Non-Hodgkin Lymphoma(NHL).
    Leucemia mieloide aguda (LMA)/síndrome mielodisplásico (SMD) de alto
    riesgo, mieloma múltiple (MM) y linfoma no hodgkiniano (LNH)
    E.1.1.1Medical condition in easily understood language
    AML Cancer of the blood/bone marrow.
    High-risk MDS Cancer of the bone marrow.
    MM Cancer of the blood arising from plasma cells.
    NHL A group of cancers that includes all types of lymphoma except NH.
    AML Cáncer de sangre/médula ósea (MO)
    MDS alto riesgo Cáncer de MO
    MM Cáncer de sangre que surge de las células plasmáticas
    NHL Grupo de cánceres que incluye todos los tipos de linfoma excepto NH
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of CCS1477 in patients with blood/bone marrow cancers.
    Investigar la seguridad y tolerabilidad de CCS1477 en pacientes con cáncer en sangre/médula ósea.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of CCS1477 in patients with blood/bone marrow cancers.

    To understand how the body handles the study medication (pharmacokinetics) of CCS1477, following a single dose and after multiple dosing.
    Investigar la eficacia de CCS1477 en pacientes con cáncer en sangre/médula ósea.
    Comprender cómo el cuerpo maneja la medicación del estudio (farmacocinética) de CCS1477, después de una dosis única y después de
    dosis múltiples.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.

    2.Willing and able to participate in all required evaluations and procedures in this study protocol.

    3.Men and women ≥18 years of age.

    4.Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

    5.Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML). Patients will include but are not limited to the following:
    •B-cell non-Hodgkin lymphoma (including Richter’s Syndrome)
    •T-cell non-Hodgkin lymphoma
    •Multiple myeloma
    •AML/secondary AML (patients with acute promyelocytic leukemia (APL) (FAB subtype M3) will be excluded).
    •High-risk MDS; according to revised International Prognostic Scoring System (IPSS-R).

    6.Must have received standard therapy (for the majority of therapeutic indications - at least 2 prior lines of therapy) - refer to relevant disease guidelines, such as European Society for Medical Oncology (ESMO), International Myeloma Working Group (IMWG) or National Comprehensive Cancer Network (NCCN) guidelines. In circumstances where there may be no standard of care, or intensive treatment would not be tolerable or is refused, patients may be considered eligible for the study upon consultation and agreement between the medical monitor and the treating Investigator.

    7.Adequate haematologic function defined as:
    •Absolute neutrophil count (ANC) ≥1000 cells/mm3 (1.0 x 10^9/L).
    •Platelet count without requiring ongoing blood product support ≥75,000 cells/mm3 (75 x 10^9/L). Platelet transfusions are not permitted within 3 days of screening.
    •Haemoglobin level ≥80 g/L.
    This criterion does not apply to AML/MDS patients. Patients with other malignancies involving bone marrow with parameters below the threshold may be considered eligible following discussion with the medical monitor.
    •For AML, WBC must be <10,000/µl.

    8.Adequate organ function at screening defined as:
    •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN), or AST/ALT ≤5 x ULN (with underlying liver involvement following discussion with the medical monitor).
    •Total bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, patients with borderline elevation due to underlying liver involvement may be eligible following discussion with the medical monitor).
    •Serum creatinine <1.5 x ULN, OR creatinine clearance ≥50 mL/min as measured or calculated by Cockcroft and Gault equation, or ≥30 mL/min in patients with kidney function affected by the underlying malignancy
    •Serum albumin >2.5 g/dL
    1. Otorgar el consentimiento informado por escrito firmado y fechado antes de que se realice cualquier procedimiento, muestreo y análisis específicos del estudio.
    2. Disposición y capacidad para participar en todas las evaluaciones y procedimientos requeridos en este protocolo del estudio.
    3. Hombres y mujeres ≥18 años de edad.
    4. Estado funcional ≤2 según la escala del Eastern Cooperative Oncology Group (ECOG).
    5. Pacientes con neoplasias hematológicas recidivantes o resistentes al tratamiento (LNH, MM y LMA) confirmadas (según los criterios diagnósticos de la enfermedad de referencia). Los pacientes incluirán, entre otros, los siguientes:
    •Linfoma no hodgkiniano de linfocitos B (incluido el síndrome de Richter)
    •Linfoma no hodgkiniano de linfocitos T
    •Mieloma múltiple
    •Leucemia Mieloide Aguda/Leucemia Mieloide Aguda secundaria (pacientes con leucemia promielocítica aguda [LPA] [FAB subtipo M3] quedan excluidos).
    •SMD de alto riesgo, según el sistema de puntuación pronóstico internacional revisado (IPSS-R).
    6. Debe haber recibido el tratamiento habitual (para la mayoría de las indicaciones terapéuticas, al menos 2 líneas previas de tratamiento); consulte las directrices sobre la enfermedad correspondiente, como las de la Sociedad Europea de Oncología Médica (ESMO), el Grupo de Trabajo Internacional sobre el Mieloma (IMWG) o la Red Nacional Integral del Cáncer (NCCN). En circunstancias en las que no exista un tratamiento de referencia, o el tratamiento intensivo no fuera tolerable o se rechace, los pacientes podrán considerarse aptos para el estudio tras consulta y acuerdo entre el monitor médico y el investigador responsable del tratamiento.
    7. Función hematológica aceptable definida como:
    •Recuento absoluto de neutrófilos (RAN) ≥1000 células/mm3 (1,0 × 109/l).
    •Recuento de plaquetas sin necesidad de administración continua de hemoderivados ≥75 000 células/mm3 (75 × 109/l). No se permiten las transfusiones de plaquetas en los 3 días anteriores a la selección.
    •Nivel de hemoglobina ≥80 g/l. Este criterio no es aplicable a los pacientes con LMA/SMD. Los pacientes con otras neoplasias malignas en médula ósea con parámetros inferiores al valor umbral pueden considerarse aptos tras acordarlo con el monitor médico.
    •Para la LMA, la cifra de leucocitos debe ser <10 000/μl.
    8. Función orgánica aceptable en la selección, definida como:
    •Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤3 veces el límite superior de la normalidad (LSN) o AST/ALT ≤5 veces el LSN (con afectación hepática subyacente tras consultar con el monitor médico).
    •Bilirrubina total ≤1,5 veces el LSN (a menos que el aumento de la bilirrubina se deba al síndrome de Gilbert o tenga origen extrahepático, los pacientes con elevación limítrofe por afectación hepática subyacente pueden ser aptos tras comentarlo con el monitor médico).
    •Creatinina sérica <1,5 veces el LSN, O aclaramiento de creatinina ≥50 ml/min medido o calculado mediante la ecuación de Cockcroft y Gault, o ≥30 ml/min en pacientes con función renal afectada por la neoplasia subyacente
    •Albúmina sérica >2,5 g/dl
    E.4Principal exclusion criteria
    Patients must not enter the study if any of the following exclusion criteria are fulfilled

    1.Treatment with any of the following:
    •Any investigational agent, chemotherapy, immunotherapy or anticancer agents from a previous clinical study within 14 days or 5 half-lives of first dose of study treatment. Shorter wash-out may be considered for immunotherapies after discussion with medical monitor.
    •Strong inducers of CYP3A4 taken within 4 weeks of the first dose of study treatment or whilst on study treatment.
    •Strong inhibitors of CYP3A4, CYP3A4 substrates with a narrow therapeutic range, CYP2C8 substrates with a narrow therapeutic range or CYP3A4 sensitive substrates taken within 2 weeks of the first dose of study treatment or while on study treatment.
    Washout periods may be reduced for specific medications (eg. statins) following discussion with the medical monitor.
    •Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment; palliative radiotherapy to ≤30% of the bone marrow within 2 weeks of the first dose of study treatment. A shorter wash-out period may be considered for palliative radiotherapy after discussion with medical monitor.
    •Herbal medications taken within 7 days of the first dose of study treatment (4 weeks for St John’s wort) or while on study treatment.
    •Statins; patients should discontinue statins 5 half-lives prior to starting study treatment.
    •Steroids use >10mg daily prednisolone or equivalent within 2 weeks of the first dose of study treatment.
    •Major surgery within 4 weeks of the first dose of study treatment.

    2.With the exception of alopecia, and CTCAE Grade 2 neuropathy, any unresolved toxicities from prior therapy > Grade 1 at the time of starting study treatment.

    3.Presence of, or history of, CNS lymphoma, symptomatic leptomeningeal disease, or spinal cord compression.

    4.History of prior non-haematologic malignancy except for the following:
    •Adequately treated carcinoma in situ or non-melanomatous skin cancer
    •Malignancy treated with curative intent or in remission for >6 months after the last therapy may be eligible after discussion with medical monitor. Maintenance treatment (eg. hormonal therapy) is allowed.

    5.Any evidence of severe or uncontrolled systemic disease (e.g. current unstable or uncompensated respiratory or cardiac conditions; history of, or active, bleeding diatheses; uncontrolled active systemic infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)*), which in the investigator’s opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol.
    *Active viral infection is defined as requiring antiviral therapy. Screening for chronic conditions is not required.

    6.Repeatable QTcF prolongation (>480 msec).

    7.History of severe allergic or anaphylactic reactions or history of hypersensitivity to active or inactive excipients of CCS1477.

    8.Female patients who are pregnant or breast-feeding at study entry.

    9.Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
    1. Tratamiento con cualquiera de los siguientes:
    •Cualquier fármaco en investigación, quimioterapia, inmunoterapia o antineoplásicos de un estudio clínico previo en los 14 días o 5 semividas anteriores a la primera dosis del tratamiento del estudio. Se puede considerar un reposo farmacológico más breve para las inmunoterapias tras comentarlo con el monitor médico.
    •Inductores potentes de la isoenzima CYP3A4 administrados en las 4 semanas previas a la primera dosis del tratamiento del estudio o durante el tratamiento del estudio
    •Inhibidores potentes de la isoenzima CYP3A4, sustratos de CYP3A4 con un margen terapéutico estrecho, sustratos de la isoenzima CYP2C8 con un margen terapéutico estrecho o sustratos sensibles de la CYP3A4 administrados en las 2 semanas previas a la primera dosis del tratamiento del estudio o durante el tratamiento del estudio.
    -Los períodos de reposo farmacológico pueden reducirse en caso de medicamentos específicos (p. ej., estatinas) tras comentarlo con el monitor médico.
    •Radioterapia con un campo amplio de radiación o más del 30 % de la médula ósea en las 4 semanas previas a la primera dosis del tratamiento del estudio; radioterapia paliativa en ≤30 % de la médula ósea en las 2 semanas previas a la primera dosis del tratamiento del estudio. Puede considerarse un período de reposo farmacológico más breve para la radioterapia paliativa tras comentarlo con el monitor médico.
    •Los medicamentos a base de hierbas tomados en los 7 días anteriores a la primera dosis del tratamiento del estudio (4 semanas para la hierba de San Juan) o durante el tratamiento del estudio.
    •Estatinas; los pacientes deben suspender la administración de estatinas 5 semividas antes del inicio del tratamiento del estudio.
    •Uso de corticosteroides en una dosis >10 mg de prednisolona o equivalente al día en las 2 semanas previas a la primera dosis del tratamiento del estudio.
    •Cirugía mayor en las 4 semanas previas a la primera dosis del tratamiento del estudio.
    2. Con la excepción de la alopecia y la neuropatía de grado 2 según los CTCAE, cualquier toxicidad no resuelta de grado >1 por un tratamiento previo en el momento del inicio del tratamiento del estudio.
    3. Presencia o antecedentes de linfoma con afectación del SNC, enfermedad leptomeníngea sintomática o compresión medular.
    4. Antecedentes de neoplasia no hematológica previa, excepto las siguientes:
    •Carcinoma in situ o cáncer de piel no melanomatoso adecuadamente tratado
    •La neoplasia tratada con intención curativa o en remisión durante >6 meses después del último tratamiento puede ser aceptable tras consultar con el monitor médico. Se permite el tratamiento de mantenimiento (p. ej., hormonoterapia).
    5. Cualquier signo de enfermedad sistémica grave o no controlada (por ejemplo, afecciones respiratorias o cardíacas actuales inestables o no compensadas; antecedentes o presencia activa de diátesis hemorrágicas; infección sistémica activa no controlada, incluidas la hepatitis B, lahepatitis C y la infección por el virus de la inmunodeficiencia humana [VIH]*), que en opinión del investigador haga que no sea conveniente que el paciente participe en el estudio o que ponga en peligro el cumplimiento del protocolo. *La infección vírica activa se define como la necesidad de tratamiento antivírico. No se requieren pruebas de detección sistemática para afecciones crónicas.
    6. Prolongación del intervalo QTcF repetible (>480 ms)
    7. Antecedentes de reacciones alérgicas o anafilácticas graves o antecedentes de hipersensibilidad a excipientes activos o inactivos de CCS1477.
    8. Pacientes embarazadas o en periodo de lactancia en el momento de la inclusión en el estudio.
    9. Criterio del investigador de que el paciente no debe participar en el estudio si es improbable que el paciente cumpla los procedimientos, las restricciones y los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the study is:

    Safety and tolerability of CCS1477 as monotherapy.

    Safety and tolerability will be assessed in terms of AEs, laboratory data, vital signs and ECG changes. These will be collected for all patients. Appropriate summaries of these data will be presented.
    La medida de resultado principal del estudio es:
    Seguridad y tolerabilidad de CCS1477 en monoterapia.
    La seguridad y la tolerabilidad se evaluarán en términos de acontecimientos adversos (AEs), datos de laboratorio, signos vitales y cambios en el ECG. Estos se recopilarán para todos los pacientes. Se presentarán resúmenes apropiados de estos datos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs will be discussed and recorded at every visit.

    Blood and urine samples for clinical chemistry, haematology, reproductive hormones and urinalysis (dipstick) parameters will be taken at the following timepoints: Screening, Cycle 1 (D1, D8, D15, D22), Cycle 2 (D1, D15) Cycle 3 onwards D1 of every cycle, treatment disc. and 28 day follow up.

    Blood pressure, heart rate, respiration rate and temperature will be recorded at the following timepoints: Screening, Cycle 1 – Every visit (D1, D2, D8, D15, D22,), Cycle 2 - Every visit (D1, D15), Cycle 3 onwards – D1 of every cycle and treatment disc.

    ECGs will be performed at the following timepoints: Screening, Cycle 1 – D1 pre-dose and 2 hrs post-dose, D8 pre-dose and 2hrs post dose, Cycle 2 onwards – D1 of every cycle, treatment disc.
    Los AA se analizarán y registrarán en cada visita.
    Muestras de sangre para bioquímica, hematología, y de orina para su análisis (tira reactiva) en: screening, Ciclo 1-D1, D8, D15, D22, Ciclo 2 (D1, D15), Ciclo 3 en adelante-Día 1 de cada ciclo, suspensión de tratamiento y seguimiento a los 28 días.
    La presión arterial, frecuencia cardíaca, frecuencia respiratoria y temperatura se registrarán en: screening, Ciclo 1 - Cada visita (D1, D2, D8, D15, D22), Ciclo 2 - Cada visita (D1, D15), Ciclo 3 en delante-Día 1 de cada ciclo y suspensión de tratamiento.
    Los ECG se realizarán en: screening, Ciclo 1: predosis D1 y 2hr posdosis, predosis D8 y 2hr posdosis, Ciclo 2 en adelante-Día 1 de cada ciclo y suspensión de tratamiento.
    E.5.2Secondary end point(s)
    To characterise the pharmacokinetics (PK) of CCS1477, following a single dose and at steady state after multiple dosing.

    To assess preliminary tumour response/activity of CCS1477 in patients with relapsed or refractory haem. malignancies (NHL, MM and AML/high-risk MDS).
    Anti-tumour activity defined by measurement of changes in:
    NHL - Radiological assessment, bone marrow disease status and serum immunoglobulins.
    MM - Blood/urine samples for myeloma response, bone/bone marrow disease status and serum immunoglobulins.
    AML - Bone marrow disease status.

    To obtain a preliminary assessment of CCS1477 by evaluation of overall survival (OS).
    Caracterizar la farmacocinética (PK) de CCS1477, después de una dosis única y en estado estacionario después de dosis múltiples.
    Evaluar la respuesta/actividad tumoral preliminar de CCS1477 en pacientes con malignidades hematológicas recidivantes o refractarias (NHL, MM y AML / MDS de alto riesgo).
    Actividad antitumoral definida por la medición de cambios en:
    -LNH: evaluación radiológica, estado de enfermedad en la médula ósea e inmunoglobulinas séricas.
    -MM: muestras de sangre / orina para respuesta al mieloma, estado de enfermedad ósea / médula ósea e inmunoglobulinas séricas.
    -AML: estado de enfermedad en la médula ósea.
    Obtener una evaluación preliminar de CCS1477 mediante la evaluación de la supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK Blood
    C1D1, 2 & 3 (single dose)
    Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10, 24 -D2 & 48hr -D3 pre-dose
    C1 & C2 (multiple dose)
    Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 & 24hr pre-dose

    NHL
    CT/MRI/FDG-PET: Scr, WK8, every 12wks until progression
    BM biopsy/aspirate: Scr, to confirm CR
    Serum Ig: Scr, as per disease guidelines

    MM
    Myeloma Response (blood/urine): Scr, C1D1, D1 of every cycle, disc.
    BM biopsy/aspirate: Scr, to confirm CR
    Serum Ig: Scr, C1D1, C3D1, C5D1, every 8 weeks
    Bone scan: Scr, to confirm CR

    AML
    BM biopsy/aspirate: Scr, C2D1, C4D1, C6D1

    Peripheral blood
    Blast count and exploratory biomarkers: Scr, C1D1, D1 of every cycle, C7+ as clinically indicated

    OS until sufficient data collected
    PK sangre
    C1D1, 2 y 3 (dosis única): Predosis, 0.5, 1, 1.5, 2, 4, 8, 10, 24 -D2 y 48hr -D3 predosis
    C1 y C2 (dosis múltiples): Predosis, 0.5, 1, 1.5, 2, 4, 8, 10 y 24hr de predosis

    NHL
    TAC/RM/FDG-PET: basal (Scr), sem 8, cada 12sem hasta progresión
    Biopsia/aspiración MO: Scr, para confirmar RC
    Ig sérica: Scr, según pautas de la enfermedad

    MM
    Respuesta del mieloma (sangre/orina): Scr, C1D1, D1 de cada ciclo, interrupción tto.
    Biopsia/aspiración MO: Scr, para confirmar RC
    Ig sérica: Scr, C1D1, C3D1, C5D1, cada 8sem
    Escaneo óseo: Scr, para confirmar RC

    AML
    Biopsia/aspiración MO: Scr, C2D1, C4D1, C6D1
    Sangre periférica
    Recuento de blastos y biomarcadores exploratorios: Scr, C1D1, D1 de cada ciclo, C7 + según indicación clínica

    SG hasta recopilar datos suficientes
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, efficacy, dose escalation
    Seguridad, eficacia, escalada de dosis
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    France
    Netherlands
    Spain
    Sweden
    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 end of the study is defined as the later of the last patient completing study treatment and the 28-day follow-up visit or 9 months after the last patient has been enrolled. Overall survival will be collected for patients and collection of this data may continue after the last patient has completed study treatment.
    El final del estudio se define como el último paciente que completó el tratamiento del estudio y la visita de seguimiento de 28 días o 9 meses después de que se haya inscrito al último paciente, lo último que ocurra. Se recopilará la supervivencia global de los pacientes y la recopilación de estos datos puede continuar después de que el último paciente haya completado el tratamiento del estudio.
    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 months8
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 90
    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)
    Patients will be treated until disease progression or until they withdraw from the study. Arrangements for care after the study has ended will be discussed with their Doctor.
    Los pacientes serán tratados hasta la progresión de la enfermedad o hasta que se retiren del estudio. Los arreglos para la atención una vez finalizado el estudio se analizarán con su médico.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-16
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