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    Summary
    EudraCT Number:2022-000131-23
    Sponsor's Protocol Code Number:CA116-003
    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:2022-09-27
    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 number2022-000131-23
    A.3Full title of the trial
    A Phase 2 Open-label Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants with Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies
    Estudio en fase II abierto y aleatorizado de MORAb-202 (farletuzumab ecteribulina), un conjugado de anticuerpo y fármaco dirigido al receptor α de folato, en participantes con adenocarcinoma (AC) de pulmón no microcítico (ACPNM) metastásico después de haber progresado con tratamientos anteriores
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 Study of MORAb-202 in Previously Treated Metastatic NSCLC AC
    Estudio en fase II de MORAb-202 en ACPNM metastásico tratado previamente
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 Study of MORAb-202 in Previously Treated Metastatic NSCLC AC
    Estudio en fase II de MORAb-202 en ACPNM metastásico tratado previamente
    A.4.1Sponsor's protocol code numberCA116-003
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1273-2077
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol -Myers Squibb International Corporation Belgium
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol -Myers Squibb International Corporation
    B.5.2Functional name of contact pointHead of the GSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine - l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameMORAb-202
    D.3.2Product code BMS-986445
    D.3.4Pharmaceutical form Lyophilisate 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 INNFarletuzumab ecteribulin
    D.3.9.2Current sponsor codeBMS-986445
    D.3.9.4EV Substance CodeSUB215766
    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 Yes
    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.3.1Product nameMORAb-202
    D.3.2Product code BMS-986445
    D.3.4Pharmaceutical form Lyophilisate 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 INNFarletuzumab ecteribulin
    D.3.9.2Current sponsor codeBMS-986445
    D.3.9.4EV Substance CodeSUB215766
    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 Yes
    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
    Metastatic Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico metastásico
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Cancer that has spread (metastasized) beyond the lung
    Cáncer de células no pequeñas que se ha extendido (metastatizado) más allá del pulmón.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess safety and tolerability of MORAb-202 in participants with previously treated, metastatic non-small cell lung cancer (NSCLC) adenocarcinoma (AC)
    2. To assess tumor response of MORAb-202 in participants with previously treated, metastatic NSCLC AC
    Evaluar la seguridad y la tolerabilidad de MORAb-202 en participantes con adenocarcinoma de pulmón no microcítico (ACPNM) metastásico tratado previamente.
    Evaluar la respuesta tumoral de MORAb-202 en participantes con ACPNM metastásico tratado previamente.
    E.2.2Secondary objectives of the trial
    1. To evaluate progression-free survival (PFS) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
    2. To evaluate disease control rate (DCR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
    3. To evaluate duration of response (DoR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC who achieved a complete response (CR) or partial response (PR)
    1. Evaluar la supervivencia sin progresión (SSP) de MORAb-202 en participantes con ACPNM metastásico tratado previamente.
    2. Evaluar la tasa de control de la enfermedad (TCE) de MORAb-202 en participantes con ACPNM metastásico tratado previamente.
    3. Evaluar la duración de la respuesta (DR) de MORAb-202 en participantes con ACPNM metastásico tratado previamente que alcanzaron una respuesta completa (RC) o una respuesta parcial (RP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Participants or legally acceptable representatives who signed Written Informed Consent
    2) Participants (male or female) must be 18 years or older at the time of signing the informed consent
    3) Participants with histologically or cytologically documented metastatic NSCLC adenocarcinoma (AC)
    4) Participants without genetic alterations or unknown genetic alterations in the metastatic setting after receiving:
    a) 1 prior line of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given concurrently or
    b) 2 prior lines of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given sequentially
    5) Participants with known targetable genetic alterations in the metastatic setting after receiving:
    a) at least 1 approved targeted therapy and
    b) no more than 3 prior lines of systemic therapy (including no more than 1 line of chemotherapy)

    6) Investigator-assessed radiologically documented disease progression during or after last treatment
    7) Measurable target disease assessed by the investigator according to RECIST 1.1.
    8) Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.
    9) ECOG PS of 0 or 1
    10) Participants with available FFPE tissue block, newly cut unstained slides, or newly obtained biopsies that are evaluable for IHC analysis
    1. Los participantes o representantes legales deben haber firmado y fechado un formulario de consentimiento informado (FCI) por escrito.
    2. Los participantes (varones o mujeres) deben tener 18 o más años de edad en el momento de la firma del consentimiento informado.
    3. AC de CPNM metastásico documentado histológica o citológicamente.

    4. participantes sin alteraciones genéticas o alteraciones genéticas desconocidas en el contexto metastásico son elegibles después de recibir:
    a. una (1) línea de tratamiento previa si se administró quimioterapia doble con platino y anti-PD-1/PD-L1 de forma ।simultánea.
    b. dos (2) líneas de tratamiento previas si se administró quimioterapia doble con platino y anti-PD-1/PD-L1 de forma secuencial.

    5. Los participantes con alteraciones genéticas conocidas susceptibles de utilizarse como diana de tratamiento en el contexto metastásico son elegibles después de recibir:
    a. al menos 1 tratamiento dirigido aprobado y
    b. no más de 3 líneas previas de tratamiento sistémico (incluida no más de 1 línea de quimioterapia).

    6. Progresión de la enfermedad documentada radiológicamente evaluada por el investigador durante o después del último tratamiento
    7. Enfermedad diana medible evaluada por el investigador de acuerdo con los criterios RECIST 1.1.
    8. Las lesiones a las que se haya aplicado radioterapia con haz de electrones (EBRT, siglas en inglés), o bien los tratamientos locorregionales como ablación con radiofrecuencia (RF), deberán mostrar evidencia de progresión en la enfermedad basándose en RECIST 1.1 para ser consideradas lesiones diana.
    9. EF del ECOG de 0 o 1.
    10. Antes de la aleatorización, debe disponerse de bloques de tejido FFIP (preferible), cortes nuevos sin teñir o biopsias recién obtenidas para su evaluación mediante IHQ en un laboratorio central.
    E.4Principal exclusion criteria
    Medical Conditions
    -NSCLC histologies other than adenocarcinoma (AC)
    -Pulmonary Function Test (PFT) abnormalities
    -Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed >12 months before treatment
    -Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented >6 months before starting study treatment
    -Current infectious pneumonia (including COVID-19-related infection), history of viral pneumonia with evidence of persistent radiologic abnormalities
    -Investigator assessed current ILD/pneumonitis or ILD/pneumonitis is suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy
    -Participants with an active, known or suspected autoimmune disease, connective tissue, or inflammatory disorders with documented pulmonary involvement

    Prior/Concomitant Therapy
    -Participants who have received prior investigational treatment with FRα-targeting agent, or FRα-targeting ADCs including MORAb-202.
    -Any condition requiring folate supplementation (eg, folate deficiency).
    -Any major surgery within 4 weeks of the first dose of study treatment

    Physical and Laboratory Test Findings
    -Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
    Afecciones médicas
    -Histologías de CPNM distintas de AC
    -Anomalías en la prueba de la función pulmonar (PFP).
    -Neumonectomía previa. Se permiten la lobectomía y la segmentectomía previas >12 meses antes del tratamiento.
    -Radioterapia torácica reciente. Los participantes con radiación en el pecho o la pared torácica pueden estar permitidos si la radiación torácica se documenta >6 meses antes de iniciar el tratamiento del estudio.
    -Neumonía infecciosa actual (incluida la infección relacionada con el COVID-19), antecedentes de neumonía vírica con indicios de anomalías radiológicas persistentes.
    -Se sospecha o se conoce la existencia de una EPI/neumonitis evaluada por el investigador o de una EPI/neumonitis en la selección o hay antecedentes de EPI/neumonitis de cualquier intensidad, incluidas las EPI/neumonitis por un tratamiento antineoplásico previo.

    Tratamiento previo/concomitante
    -Participantes que han recibido tratamiento en investigación previo con un fármaco dirigido a FRα o CAF dirigido a FRα, incluido MORAb-202.
    -Cualquier afección que requiera aporte complementario de folato (p. ej., deficiencia de folato).
    -Haberse sometido a una cirugía mayor en las 4 semanas previas a la primera dosis del tratamiento del estudio.

    Resultados de las pruebas físicas y los análisis de laboratorio
    -Indicios de disfunción orgánica o cualquier desviación clínicamente significativa de la normalidad en la exploración física, las constantes vitales, el ECG o las determinaciones analíticas clínicas más allá de lo que es coherente con la población a la que va dirigido.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and severity of adverse events (AEs)/serious AEs (SAEs),
    treatment related AEs/SAEs, AEs leading to discontinuation, AEs of
    special interest (AESI), deaths and laboratory abnormalities.
    Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
    -Incidencia de acontecimientos adversos relacionados con el tratamiento (AART) que provoquen la interrupción del tratamiento del estudio.
    -Tasa de respuesta objetiva (TRO) según los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1, y la evaluación del investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after last patient completed a maximum of 2 year study treatment or the date of discontinuation, whichever occurred first.
    30 días después de que el último paciente haya completado un máximo de 2 años de tratamiento del estudio o la fecha de interrupción, lo que ocurra primero.
    E.5.2Secondary end point(s)
    -Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs of special interest (AESI), deaths and laboratory abnormalities.

    -PFS by RECIST 1.1 per investigator assessment
    -Incidencia e intensidad de acontecimientos adversos (AA)/AA graves (AAG), AA/AAG relacionados con el tratamiento, AA de interés especial (AAEI), muertes y anomalías analíticas.

    -SSP, TCE y DR según los criterios RECIST 1.1 y la evaluación del investigador
    E.5.2.1Timepoint(s) of evaluation of this end point
    -30 days after last patient completed a maximum of 2 year study treatment or the date of discontinuation, whichever occurred first.


    -All participants in each arm have been followed up for a minimum of 6 months.
    -30 días después de que el último paciente haya completado un máximo de 2 años de tratamiento del estudio o la fecha de interrupción, lo que ocurra primero.


    -Todos los participantes de cada grupo han sido objeto de seguimiento durante un mínimo de 6 meses.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Chile
    United States
    France
    Spain
    Belgium
    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
    End of study is defined as all randomized participants who complete their last visit or scheduled procedure.
    El final del estudio se define como todos los participantes aleatorizados que completen su última visita o procedimiento programado.
    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 months6
    E.8.9.1In the Member State concerned days8
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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)
    Since this is a dose-optimizing study, at the end of the study, BMS will not continue to provide BMS supplied study intervention to participants or investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.
    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 Decision2023-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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