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    Summary
    EudraCT Number:2019-001908-38
    Sponsor's Protocol Code Number:R5093-ONC-1863
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-05-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001908-38
    A.3Full title of the trial
    A PHASE 1/2 STUDY OF REGN5093 IN PATIENTS WITH MET-ALTERED ADVANCED NON-SMALL CELL LUNG CANCER
    Étude de phase I/II portant sur REGN5093 chez des patients atteints d'un
    cancer du poumon non à petites cellules avancé avec altération de MET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REGN5093 in Patients with MET-Altered Advanced Non-Small Cell Lung Cancer
    Évaluation du REGN5093 dans le traitement du cancer bronchique non à
    petites cellules avancé avec altération de MET
    A.4.1Sponsor's protocol code numberR5093-ONC-1863
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 nameREGN5093
    D.3.2Product code REGN5093
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.3Other descriptive nameREGN5093
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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
    Non-small cell lung cancer
    Cancer bronchique non à petites cellules
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer
    Cancer bronchique non à petites cellules
    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
    In the dose escalation phase:
    • To assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered non-small cell lung cancer (NSCLC)

    In the dose expansion phase:
    • To assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
    L’objectif principal de la phase d’escalade de dose (phase 1) de l’étude est le suivant :
    • Évaluation de la sécurité, de la tolérance et de la pharmacocinétique (PK) du REGN5093 pour la détermination de la dose maximum tolérée (DMT) et/ou la détermination de la dose recommandée pour la phase 2 (DRP2) du REGN5093 chez des patients atteints d’un cancer du poumon non à petites cellules (CPNPC) avec altération de MET.

    L’objectif principal de la phase d’extension de dose (phase 2) de l’étude est le suivant :
    • Évaluation préliminaire de l’activité antitumorale du REGN5093 mesurée par le taux de réponse objective (TRO) selon les Critères d’évaluation de réponse dans les tumeurs solides (Response Evaluation Criteria in Solid Tumors) (RECIST 1.1)
    E.2.2Secondary objectives of the trial
    In the dose escalation phase:
    • To assess preliminary anti-tumor activity of REGN5093 as measured by the ORR per RECIST 1.1

    In the dose expansion phase:
    • To assess the safety and tolerability of REGN5093 in each expansion cohort
    • To assess REGN5093 PK and concentrations in serum

    In both parts of the study:
    • To assess immunogenicity as measured by anti-drug antibodies (ADA) to REGN5093
    • To evaluate other measures of preliminary anti-tumor activity
    L’objectif secondaire de la phase d’escalade de dose (phase 1) de l’étude est le suivant :
    • Évaluation préliminaire de l’activité antitumorale du REGN5093 mesurée par le TRO selon RECIST 1.1

    Les objectifs secondaires de la phase d’extension de dose (phase 2) de l’étude sont les suivants :
    • Évaluation de la sécurité et de la tolérance du REGN5093 dans chaque cohorte d’extension
    • Évaluation de la PK et des concentrations sériques du REGN5093
    Les objectifs secondaires des deux phases de l’étude sont :
    • Évaluation de l’immunogénicité mesurée par la présence d’anticorps antimédicament (AAM) dirigés contre le REGN5093
    • Évaluation d’autres mesures de l’activité antitumorale préliminaire.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional genomics sub-study:
    The purpose of the pharmacogenomic analyses is to identify genomic associations with clinical or biomarker response to REGN5093, other lung cancer clinical outcome measures, and possible AEs.
    Sous-étude facultative de génomique:
    Le but des analyses pharmacogénomiques est d'identifier les associations génomiques avec la réponse clinique ou biomarqueur à REGN5093, d'autres mesures des résultats cliniques du cancer du poumon et d'éventuels EIs.
    E.3Principal inclusion criteria
    1: Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patients must have exhausted all approved available therapies appropriate for the patient.
    2: Has available archival tumor tissue, unless discussed with the medical monitor.
    3: Willing to provide tumor tissue from newly obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed with the medical monitor. For patients in expansion cohorts, biopsies should be taken from tumor site which has not been irradiated previously and is not the only measurable target lesion.
    4: Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression, as defined in the protocol

    Other protocol-defined Inclusion criteria apply
    1.CPNPC confirmé histologiquement qui est au stade avancé et pour lequel il n’existe aucune option thérapeutique standard susceptible de procurer un bénéfice clinique. Avancé est défini comme signifiant non opérable ou maladie métastatique. Les patients doivent avoir épuisé toutes les thérapies approuvées disponibles appropriés pour eux.
    2. Du tissu tumoral archivé doit être disponible, sauf après discussion avec le moniteur médical.
    3. Patient prêt à fournir du tissu tumoral obtenu par nouvelle biopsie. Des biopsies nouvellement obtenues à la sélection sont requises sauf en cas de contre-indication médicale et après discussion avec le moniteur d’études cliniques. Pour les patients dans les cohortes d’extension, le biopsies doivent être obtenues d’un site tumoral n’ayant pas été préalablement irradié et qui ne constitue pas l’unique lésion cible mesurable.
    4.Présence précédemment documentée d'altérations MET: mutation du gène MET-exon14 et / ou amplification du gène MET, et / ou expression élevée de la protéine MET, comme défini dans le protocole

    D'autres critères d'inclusion définis par le protocole s'appliquent
    E.4Principal exclusion criteria
    1: Has not yet recovered (i.e. grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except for:
    - laboratory changes as described in the protocol, and
    - patients with grade ≤2 neuropathy
    For immune-related AEs (irAEs) affecting any organ system within 2 months prior to enrollment there must be documentation of a trajectory of improvement of this irAE (to grade ≤1 or baseline by the time of enrollment) AND for those toxicities that remain at grade 1, documentation of 2 stable evaluations separated by at least 4 weeks
    2: Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. grade ≤1 or baseline) from AEs, except for laboratory changes as described in the protocol and patients with grade ≤2 neuropathy
    3: For expansion cohorts only: prior treatment with MET-targeted biologic therapy (function-blocking antibodies or ADCs) and with any MET-targeted agent including small molecule tyrosine kinase inhibitors eg, crizotinib, capmatinib, tepotinib, as defined in the protocol
    4: Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol

    Other protocol-defined Exclusion criteria apply.
    1.N’a pas encore récupéré de toxicités aiguës d’un traitement antérieur (c’est-à-dire résolution au grade ≤1 ou retour à la situation initiale) sauf pour les changements biologiques tels que décrits dans les critères d’inclusion et pour les patients ayant une neuropathie de Grade ≤ 2.
    2.A reçu une radiothérapie ou une intervention chirurgicale majeure dans les 14 jours précédant la première administration du médicament de l’étude ou n’a pas encore récupéré d’EI (c’est-à-dire résolution au grade ≤1 ou retour à la situation initiale) sauf pour les changements biologiques tels que décrits dans les critères d’inclusion et pour les patients ayant une neuropathie de Grade ≤ 2.
    3.Pour les cohortes d’extension uniquement : traitement antérieur avec une thérapie biologique ciblant MET (anticorps bloquant les fonctions ou conjugués anticorps-médicaments). et traitement antérieur par tout agent ciblant MET, comprenant les inhibiteurs de tyrosine kinase à petites molécules, par ex. crizotinib, capmatinib, tepotinib.
    4. Tumeur cérébrale primitive active ou non traitée, métastases du SNC, maladie leptoméningée ou compression médullaire.

    D'autres critères d'exclusion définis par le protocole s'appliquent
    E.5 End points
    E.5.1Primary end point(s)
    In the dose escalation phase:
    • Number of patients with Dose Limiting Toxicities (Up to 21 days)
    • Incidence and severity of treatment-emergent adverse events (Through study completion, an average of 4 years)
    • Incidence and severity of adverse events of special interest (AESIs) (Through study completion, an average of 4 years)
    • Incidence and severity of serious adverse events (SAEs) (Through study completion, an average of 4 years)
    • Incidence and severity of grade ≥3 laboratory abnormalities (Through study completion, an average of 4 years)
    • REGN5093 concentrations in serum over time (Through study completion, an average of 4 years)

    In the dose expansion phase:
    • Objective response rate (ORR) per RECIST 1.1 (Through study completion, an average of 4 years)
    Dans la phase d'augmentation de la dose:
    • Nombre de patients présentant des toxicités limitant la dose (jusqu'à 21 jours)
    • Incidence et sévérité des événements indésirables apparus sous traitement (jusqu'à la fin de l'étude, en moyenne 4 ans)
    • Incidence et sévérité des événements indésirables d'intérêt particulier (EIIP) (jusqu'à la fin de l'étude, en moyenne 4 ans)
    • Incidence et sévérité des événements indésirables graves (EIG) (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • Incidence et sévérité des anomalies biologiques de grade ≥3 (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • Concentrations de REGN5093 dans le sérum au fil du temps (jusqu'à la fin de l'étude, une moyenne de 4 ans)

    Dans la phase d'expansion de la dose:
    • Taux de réponse objectif (ORR) par RECIST 1.1 (à la fin de l'étude, une moyenne de 4 ans)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Reference the above for timeframes
    Référez-vous à ce qui précède pour les délais
    E.5.2Secondary end point(s)
    For the dose escalation phase:
    • ORR per RECIST 1.1 (Through study completion, an average of 4 years)

    For the dose expansion phase:
    • Incidence and severity of TEAEs (Through study completion, an average of 4 years)
    • Incidence and severity of AESIs (Through study completion, an average of 4 years)
    • Incidence and severity of SAEs (Through study completion, an average of 4 years)
    • Incidence and severity of grade ≥3 laboratory abnormalities (Through study completion, an average of 4 years)
    • REGN5093 Pharmacokinetics (PK) (Through study completion, an average of 4 years)
    • REGN5093 concentrations in serum over time (Through study completion, an average of 4 years)


    For both phases of the study:
    • Duration of response (DOR) per RECIST 1.1. (Through study completion, an average of 4 years)
    • Disease control rate (DCR) per RECIST 1.1. (Through study completion, an average of 4 years)
    • Progression free survival (PFS) per RECIST 1.1. (Through study completion, an average of 4 years)
    • Overall survival (OS) (Through study completion, an average of 4 years)
    • Immunogenicity as measured by anti-drug antibodies (ADA) to REGN5093 (Through study completion, an average of 4 years)
    Pour la phase d'augmentation de la dose:
    • ORR par RECIST 1.1 (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    Pour la phase d'expansion de dose:
    • Incidence et sévérité des TEAE (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • Incidence et sévérité des AESI (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • Incidence et sévérité des EIG (jusqu'à la fin de l'étude, en moyenne 4 ans)
    • Incidence et sévérité des anomalies biologiques de grade ≥3 (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • REGN5093 Pharmacocinétique (PK) (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • Concentrations de REGN5093 dans le sérum au fil du temps (jusqu'à la fin de l'étude, une moyenne de 4 ans)

    Pour les deux phases de l'étude:
    • Durée de réponse (DOR) selon RECIST 1.1. (À la fin des études, une moyenne de 4 ans)
    • Taux de contrôle des maladies (DCR) selon RECIST 1.1. (À la fin des études, une moyenne de 4 ans)
    • Survie sans progression (PFS) selon RECIST 1.1. (À la fin des études, une moyenne de 4 ans)
    • Survie globale (OS) (jusqu'à la fin de l'étude, une moyenne de 4 ans)
    • Immunogénicité mesurée par les anticorps anti-médicament (ADA) dirigés contre REGN5093 (jusqu'à la fin de l'étude, en moyenne 4 ans)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Reference the above for timeframe
    Référez-vous à ce qui précède pour les délais
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other 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 concerned7
    E.8.5The trial involves multiple Member States No
    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
    Korea, Democratic People's Republic of
    United States
    France
    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
    Dernière visite du dernier patient
    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 months4
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days19
    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.1.3Elderly (>=65 years) Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 111
    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)
    There will be a post-treatment follow-up period of 90 days for all patients.
    Il y aura une période de suivi post-traitement de 90 jours pour tous les patients.
    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 Decision2020-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-28
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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