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    Summary
    EudraCT Number:2021-004423-32
    Sponsor's Protocol Code Number:ACT17241
    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:2022-01-22
    Trial results View 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 number2021-004423-32
    A.3Full title of the trial
    Open-label, Phase 2 study, evaluating the efficacy and safety of tusamitamab ravtansine in non-squamous non-small-cell lung cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating CEA
    Estudio de fase II abierto para evaluar la eficacia y la seguridad de tusamitamab ravtansina en participantes con carcinoma pulmonar no microcítico no escamoso (CPNM NE), con tumores con expresión negativa o moderada de CEACAM5 y niveles de ACE circulante elevados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA
    Tusamitamab ravtansina en participantes con CPNM NE, con tumores con expresión negativa o moderada de CEACAM5 y ACE circulante elevado
    A.3.2Name or abbreviated title of the trial where available
    CARMEN-LC06
    A.4.1Sponsor's protocol code numberACT17241
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1264-2828
    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 Clínicos
    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 number+3493485 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.3.1Product nameTusamitamab ravtansine
    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 INNTusamitamab ravtansine
    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
    Non-squamous non-small-cell lung cancer
    Cáncer de pulmón no microcítico no escamoso
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous non-small cell lung cancer
    E.1.2System Organ Class 100000004864
    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 anti-tumor activity of tusamitamab ravtansine when given every 2 weeks (Q2W) in non squamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA) levels
    Evaluar la actividad antitumoral de tusamitamab ravtansina cuando se administra cada 2 semanas (c2s) en participantes con carcinoma pulmonar no microcítico no escamoso (CPNM NE), con tumores con expresión negativa o moderada de CEACAM5 y niveles elevados del antígeno carcinoembrionario (ACE) circulante.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of tusamitamab ravtansine
    - To assess other efficacy parameters of tusamitamab ravtansine
    - To assess immunogenicity of tusamitamab ravtansine
    - To document the pharmacokinetics (PK) of tusamitamab ravtansine
    - Evaluar la seguridad y tolerabilidad de tusamitamab ravtansina.
    - Evaluar otros parámetros de la eficacia de tusamitamab ravtansina.
    - Evaluar la inmunogenicidad de tusamitamab ravtansina.
    - Documentar la farmacocinética (FC) de tusamitamab ravtansina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
    - Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
    - At least one measurable lesion by RECIST v1.1
    - Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    - Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
    - Diagnóstico confirmado histológica o citológicamente de enfermedad metastásica de CPNM NE en el momento de inclusión en el estudio.
    - Expresión moderada o negativa de CEACAM5 evaluada mediante un análisis IHQ central en una muestra tumoral de archivo. La expresión moderada de CEACAM5 se define como una intensidad ≥2+ en ≥1 % y <50% de las células tumorales. La expresión negativa de CEACAM5 se define como una intensidad de 1+ independientemente del porcentaje de células tumorales teñidas o <1% de las células tumorales.
    - Enfermedad medible según RECIST v1.1 (Sección 10.12), determinada por el investigador. Se requiere al menos 1 lesión medible.
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) 0-1. - Mujeres en edad fértil o pacientes masculinos con mujeres en edad fértil que acepten utilizar un método anticonceptivo altamente eficaz
    E.4Principal exclusion criteria
    - Patients with untreated brain metastases or history of leptomeningeal disease.
    - 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 uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis.
    - Significant concomitant illness that could impair the participation in the study. or interpretation of the results or any major surgery with 3 weeks prior treatment administration.
    - Nonresolution 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.
    - Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
    - Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
    - Concurrent treatment with any other anticancer therapy
    - Poor bone marrow, liver or kidney functions.
    - Metástasis cerebrales no tratadas que pueden considerarse activas o antecedentes de enfermedad leptomeníngea.
    - Antecedentes de neoplasia maligna invasiva distinta de la tratada en este estudio en los 3 años anteriores, a excepción del carcinoma epidermoide o basocelular de piel o el carcinoma localizado del cuello uterino, sometidos a resección/ablación, o de otros tumores locales que se consideren curados con tratamiento local.
    - Infección incontrolada conocida con el virus de la inmunodeficiencia humana (VIH). Los participantes con infección/enfermedad por VIH bien controlada (Sección 10.10) deben estar en tratamiento antirretroviral (TAR) para ser elegibles.
    - Cualquier cirugía mayor en las 3 semanas anteriores al día 1 de la primera administración del tratamiento del estudio.
    - Cualquier cirugía mayor en las 3 semanas anteriores al día 1 de la primera administración del tratamiento del estudio.
    - Cualquier tratamiento previo dirigido a CEACAM5.
    - Trastorno corneal sin resolver o cualquier trastorno corneal previo que, en opinión de un oftalmólogo, suponga un mayor riesgo de queratopatía de origen farmacológico.
    - Tratamiento concomitante con cualquier otro tratamiento contra el cáncer.
    - Función orgánica deficiente de la médula ósea, el hígado o los riñones.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
    Tasa de respuesta objetiva (TRO) de tusamitamab ravtansina, definida como la proporción de participantes con una respuesta completa (RC) o una respuesta parcial (RP) confirmadas como la mejor respuesta global (MRG), 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 approximately 9 months after last patient treated
    Valor inicial hasta aproximadamente 9 meses después del último paciente tratado
    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
    2) Progression-free survival (PFS) defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.
    3) Disease control rate (DCR) defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1
    4) Duration of response (DOR), defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first
    5) Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
    1. Incidencia de participantes con acontecimientos adversos surgidos durante el 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 fecha de la primera administración de tusamitamab ravtansina hasta la fecha de la primera documentación de progresión de la enfermedad o muerte por cualquier causa, lo que ocurra primero.
    3. Tasa de control de la enfermedad (TCE), definida como el porcentaje de participantes que han logrado RC, RP o enfermedad estable confirmadas, como MRG según RECIST v1.1.
    4. Duración de la respuesta (DR), definida como el tiempo desde la primera evidencia documentada de RC o RP hasta la enfermedad progresiva (EP) determinada según RECIST v1.1 o la muerte por cualquier causa, lo que ocurra primero.
    5. Incidencia de participantes con anticuerpos antiterapéuticos (AAT) contra tusamitamab ravtansina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline up to approximately 90 days after the last study treatment administration
    2,3,4) Baseline up to approximately 9 months after last patient treated
    5) Baseline up to approximately 30 days after the last study treatment administration
    1) Valor inicial hasta aproximadamente 90 días después de la última administración del tratamiento del estudio
    2,3,4) Valor inicial hasta aproximadamente 9 meses después del último paciente tratado
    5) Valor inicial hasta aproximadamente 30 días después de la última administración del tratamiento 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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Belgium
    France
    Italy
    Japan
    Russian Federation
    Spain
    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
    La última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 45
    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
    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 Decision2022-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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