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    Summary
    EudraCT Number:2020-003096-18
    Sponsor's Protocol Code Number:ACT16432
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-25
    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 number2020-003096-18
    A.3Full title of the trial
    Open-label, multi-cohort, Phase 2 trial, evaluating the efficacy and safety of SAR408701 in patients with CEACAM5-positive advanced solid tumors
    Estudio de Fase 2, abierto, de múltiples cohortes para evaluar la eficacia y la seguridad de SAR408701 en pacientes con tumores sólidos avanzados positivos a CEACAM5.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SAR408701 in patients with CEACAM5-positive advanced solid tumors
    SAR408701 en pacientes con tumores sólidos avanzados positivos a CEACAM5.
    A.3.2Name or abbreviated title of the trial where available
    CARMEN-BT01
    CARMEN-BT01
    A.4.1Sponsor's protocol code numberACT16432
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1244-1644
    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 SponsorSanofi aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clinicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailes-unidadestudiosclinicos@sanofi.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 SAR408701
    D.3.4Pharmaceutical form Concentrate for solution 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 assigned
    D.3.9.2Current sponsor codeSAR408701
    D.3.9.3Other descriptive nameSAR408701
    D.3.9.4EV Substance CodeSUB130908
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti-CEACAM 5 antibody maytansine conjugate.
    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
    Cancer
    Cáncer
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast 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 21.0
    E.1.2Level PT
    E.1.2Classification code 10033610
    E.1.2Term Pancreatic carcinoma 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
    • To assess the antitumor activity of SAR408701 in metastatic breast cancer (mBC) and metastatic pancreatic adenocarcinoma (mPAC)
    • Evaluar la actividad antitumoral de SAR408701 en el cáncer de mama metastásico (CMM) y el adenocarcinoma pancreático metastásico (ACPM)
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of SAR408701
    • To assess other efficacy parameters of SAR408701
    • To assess the immunogenicity of SAR408701
    • Evaluar la seguridad y la tolerabilidad de SAR408701
    • Evaluar otros parámetros de eficacia de SAR408701
    • Evaluar la inmunogenia de SAR408701
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant must be at least 18 years of age
    Participants with at least one measurable lesion according to the RECIST v1.1 criteria that has not been irradiated (ie, newly arising lesions in previously irradiated areas are accepted).
    Participants with ECOG performance status 0 to 1.
    Evidence of metastatic disease.
    Expression of CEACAM 5 by centrally assessed IHC assay.
    Cohort A:
    Histological or cytologic diagnosis of breast cancer.
    Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic setting.
    Cohort B:
    Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
    Have documented radiographic progression or documented intolerance after at least 1 prior systemic chemotherapy line which included either gemcitabine (or relapsed within 6 months of completion of gemcitabine adjuvant therapy) or a 5-fluorouracil based regimen (including capecitabine) but no more than 2 prior chemotherapy lines for locally advanced/metastatic disease.
    Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    Capable of giving signed informed consent
    Los participantes deben tener como mínimo 18 años de edad
    Participantes al menos con una lesión medible según los criterios RECIST v1.1 no tratada con radioterapia (es decir, se aceptan lesiones de nueva aparición en zonas tratadas previamente con radioterapia
    Participantes con estado funcional ECOG de 0 a 1.
    Evidencia de enfermedad metastásica
    Expresión de CEACAM5 evaluado centralmente mediante un análisis IHQ
    Cohorte A:
    Diagnóstico histológico o citológico de cáncer de mama.
    Haber recibido al menos 2 pautas de quimioterapia citotóxica previas en el caso de los tumores no CMTN o al menos 1 en los tumores de tipo CMTN, pero no más de 4 si existe recidiva local o metástasis.
    Cohorte B:
    Tener un diagnóstico confirmado de adenocarcinoma ductal pancreático
    Tener progresión radiográfica o intolerancia documentadas después de al menos 1 línea de quimioterapia sistémica previa que haya contenido o bien gemcitabina (o que haya recidivado dentro de los 6 meses siguientes a la finalización del tratamiento adyuvante con gemcitabina) o una pauta a base de 5-fluorouracilo (incluida la capecitabina), pero no más de 2 líneas de quimioterapia previas para el cáncer localmente avanzado/metastásico.

    El uso de anticonceptivos por parte de los hombres o las mujeres debe estar en consonancia con la reglamentación local relativa a métodos anticonceptivos para sujetos que participen en estudios clínicos.
    Capacidad para otorgar el consentimiento informado firmado
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical conditions
    - Medical condition requiring concomitant administration of a medication with a narrow therapeutic window, that is metabolized by cytochrome P450 (CYP450), and for which a dose reduction cannot be considered.
    - Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before the first administration of study intervention.
    - Life expectancy less than 3 months.
    - Untreated brain metastases or history of leptomeningeal disease.
    - Significant concomitant illness
    - History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
    - History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or active hepatitis A, B or C infection.
    - Non-resolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy (HRT).
    - Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy.
    - Use of contact lenses. Participants using contact lenses who are not willing to stop wearing them for the duration of the study intervention are excluded.

    Prior/concomitant therapy
    - Concurrent treatment with any other anti cancer therapy.
    - Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for prior antitumor therapy (chemotherapy, targeted agents, immunotherapy and radiotherapy, or any investigational treatment).
    - Any prior therapy targeting CEACAM5.
    - Prior maytansinoid DM4 treatment (ADC).
    - Any major surgery within the preceding 2 weeks of the first study intervention administration.

    Prior/concurrent clinical study experience
    - Previous enrollment in this study or current participation in any other clinical study involving an investigational study treatment or any other type of medical research.

    Diagnostic assessments
    - Poor renal function
    - Poor hepatic function
    - Poor bone marrow function
    Se excluirá del estudio a los participantes que cumplan cualquiera de los siguientes criterios:
    Afecciones médicas
    - Afección médica que requiera la administración concomitante de medicamentos con un margen terapéutico estrecho, que se metabolicen a través del citocromo P450 (CYP450), y para los cuales no se pueda contemplar una reducción de la dosis.
    - Afecciones médicas que requieran la administración concomitante de inhibidores potentes de CYP3A, a menos que se puedan suspender por lo menos 2 semanas antes de la primera administración de la intervención del estudio.
    - Esperanza de vida inferior a 3 meses.
    - Metástasis cerebrales sin tratar o antecedentes de carcinomatosis leptomeníngea.
    - Enfermedades concomitantes importantes
    - Antecedentes de neoplasia maligna invasiva distinta de la tratada en este estudio en los 3 años anteriores, a excepción de la resección/extirpación de carcinoma de células basales o de células escamosas, carcinoma localizado del cuello uterino o de otros tumores locales que se consideren curados con tratamiento local.
    - Antecedentes de enfermedades conocidas relacionadas con el síndrome de inmunodeficiencia adquirida (SIDA) o infección conocida por el virus de la inmunodeficiencia humana (VIH) que requiera tratamiento antirretroviral, o infección activa por los virus de la hepatitis A, B o C
    - No resolución de cualquier toxicidad relacionada con el tratamiento previo hasta un grado <2 según los CTCAE del NCI v5.0, excepto alopecia, vitiligo o tiroiditis activa controlada con hormonoterapia restitutiva (HTR).
    - Trastorno corneal sin resolver o cualquier trastorno corneal previo considerado por un oftalmólogo para predecir un mayor riesgo de queratopatía inducida por fármacos.
    - Uso de lentes de contacto. Se excluirá a los participantes que utilicen lentes de contacto y que no quieran dejar de usarlas durante la intervención del estudio.
    Tratamiento previo/concomitante
    - Tratamiento simultáneo con cualquier otro tratamiento antineoplásico.
    - Periodo de reposo farmacológico antes de la primera administración de la intervención del estudio inferior a 3 semanas o a 5 veces la semivida, lo que sea más corto, para el tratamiento antineoplásico previo (quimioterapia, terapias dirigidas, inmunoterapia y radioterapia, o cualquier tratamiento en investigación).
    - Cualquier tratamiento previo con CEACAM5 como objetivo.
    - Tratamiento previo con maitansinoide DM4 (CAF).
    - Cualquier cirugía mayor dentro de las 3 semanas anteriores a la primera administración del tratamiento del estudio.
    Experiencia con estudios clínicos previos/actuales
    - Inclusión previa en este estudio o participación en curso en cualquier otro estudio clínico en el que se utilice un tratamiento en investigación o en cualquier otro tipo de investigación médica.
    Evaluaciones diagnósticas
    - Mala función renal
    - Mala función hepática
    - Mala función de la médula ósea
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) of SAR408701, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
    Tasa de respuesta objetiva (TRO) de SAR408701, definida como la proporción de participantes con una respuesta completa (RC) o una respuesta parcial (RP) confirmadas según los criterios de evaluación de respuesta en tumores sólidos (RECIST) v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments
    Desde la basal hasta 6 meses después de que el último paciente tratado tenga 2 evaluaciones tumorales posteriores al valor basal
    E.5.2Secondary end point(s)
    1. Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 - TEAEs, SAEs and laboratory abnormalities according to NCI CTCAE v5.0

    2. Progression free survival (PFS) - PFS defined as the time from the date of first SAR408701 administration to the date of the first documented disease progression or death due to any cause, whichever comes first

    3. Disease control rate (DCR) - DCR defined as the percentage of participants who have achieved CR, PR or stable disease as per RECIST v1.1

    4. Duration of Response (DOR) - DOR defined as the time from first documented evidence of CR or PR until progressive disease determined per RECIST v1.1 or death from any cause, whichever occurs first

    5. Incidence of participants with anti-therapeutic antibodies (ATAs) against SAR408701 - Incidence of participants with anti-therapeutic antibodies (ATAs) against SAR408701
    1. Incidencia de participantes con acontecimientos adversos derivados del tratamiento (AADT), acontecimientos adversos graves (AAG) y anomalías analíticas según los criterios terminológicos comunes para acontecimientos adversos (CTCAE) del Instituto Nacional del Cáncer (NCI) estadounidense, v5.0
    2. Supervivencia libre de progresión (SLP), definida como el tiempo transcurrido desde la primera administración de SAR408701 hasta la fecha de la primera progresión de la enfermedad o la muerte por cualquier causa documentadas, lo que ocurra primero
    3. Tasa de control de la enfermedad (DCR), definida como el porcentaje de participantes que muestren RC, RP o enfermedad estable según RECIST v1.1
    4. Duración de la respuesta (DR), definida como el tiempo transcurrido desde las primeras evidencias documentadas de RC o RP hasta la progresión de la enfermedad según RECIST v1.1, o la muerte por cualquier causa, lo que ocurra primero
    5. Incidencia de participantes con anticuerpos antiterapéuticos (AAT) contra SAR408701
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline up to 90 days after the last study treatment administration

    2. 3. and 4. Baseline up to 6 months after the last patient treated have 2 postbaseline tumor assessments

    5. Baseline up to end of study
    1. Desde la basal hasta 90 días después de la última administración del tratamiento del estudio

    2. 3. y 4. Desde la basal hasta 6 meses después de que el último paciente tratado tenga 2 evaluaciones tumorales posteriores al valor basal

    5. Desde la basal hasta el final del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cohorts
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Argentina
    Chile
    France
    Hungary
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Taiwan
    Turkey
    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
    LVLS
    Último visita del último paciente
    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 months10
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days10
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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