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    Summary
    EudraCT Number:2019-004418-32
    Sponsor's Protocol Code Number:U31402-A-U202
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-004418-32
    A.3Full title of the trial
    A MULTI-CENTER, OPEN-LABEL, PHASE 2 STUDY TO EVALUATE SAFETY AND EFFICACY OF U3-1402 IN SUBJECTS WITH ADVANCED OR METASTATIC COLORECTAL CANCER (CRC)
    Studio multicentrico, in aperto, di fase 2 volto a valutare la sicurezza e l'efficacia di U3-1402 in soggetti affetti da carcinoma colorettale (CRC) avanzato o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of U3-1402 in subjects with colorectal cancer
    Studio su U3-1402 in soggetti affetti da carcinoma colorettale
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberU31402-A-U202
    A.5.4Other Identifiers
    Name:IND numberNumber:148299
    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 SponsorDAIICHI SANKYO 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 supportDAIICHI SANKYO, INC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSyneos Health LLC
    B.5.2Functional name of contact pointLisa Ochsner
    B.5.3 Address:
    B.5.3.1Street Address1030 Sync Street
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019198769300
    B.5.5Fax number001919769360
    B.5.6E-mailLisa.Ochsner@syneoshealth.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 nameU3-1402
    D.3.2Product code [U3-1402]
    D.3.4Pharmaceutical form Powder 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 INNPatritumab deruxtecan
    D.3.9.2Current sponsor codeU3-1402
    D.3.9.4EV Substance CodeSUB204104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Advanced or metastatic colorectal cancer (CRC) which is resistant, refractory, or intolerant to at least 2 prior lines of therapy, that must include all of the following agents: fluoropyrimidine, irinotecan, platinum agent, an anti-epidermal growth factor receptor (EGFR) agent (if clinically indicated) and, unless contraindicated, an anti- vascular endothelial growth factor (VEGF) agent.
    Carcinoma colorettale (CRC) avanzato o metastatico resistenti, refrattari o intolleranti ad almeno 2 linee precedenti di terapia, che devono includere tutti i seguenti agenti: fluoropirimidina, irinotecan, agente a base di platino, un agente anti-recettore del fattore di crescita dell'epidermide (Epidermal Growth Factor Receptor, EGFR) (se indicato clinicamente) e, salvo controindicazioni, un agente anti-fattore di crescita dell'endotelio vascolare (Vascular Endothelial Growth Factor, VEGF).
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic colorectal cancer, which is resistant and refractory to at least 2 prior lines of therapy
    Carcinoma colorettale (CRC) avanzato o metastatico resistenti, refrattari o intolleranti ad almeno 2 linee precedenti di terapia
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal 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 tolerability and antitumor activity of U3-1402 in subjects with advanced or metastatic CRC who are resistant, refractory, or intolerant to at least 2 prior lines of therapy
    Valutare la tollerabilità e l'attività antitumorale di U3-1402 in soggetti affetti da CRC avanzato o metastatico, resistenti, refrattari o intolleranti ad almeno 2 precedenti linee di terapia
    E.2.2Secondary objectives of the trial
    To investigate the durability of U3-1402 antitumor activity in subjects with advanced or metastatic CRC
    To further investigate the antitumor activity of U3-1402 in subjects with advanced or metastatic CRC
    To evaluate the safety and tolerability of U3 1402 in subjects with advanced or metastatic CRC
    To evaluate HER3 protein expression in tumor tissue and its relationship with efficacy
    To assess the immunogenicity incidence against U3-1402
    To characterize the 3 PK analytes of U3-1402 in subjects with advanced or metastatic CRC
    Studiare la durata dell'attività antitumorale di U3-1402 in soggetti con CRC avanzato o metastatico
    Sottoporre a ulteriore indagine l'attività antitumorale di U3-1402 in soggetti affetti da CRC avanzato o metastatico
    Valutare la sicurezza e la tollerabilità di U3-1402 in soggetti affetti da CRC avanzato o metastatico
    Valutare l’espressione della proteina HER3 nel tessuto tumorale e la relazione con l'efficacia
    Valutare l'incidenza dell'immunogenicità diretta contro U3-1402
    Caratterizzare i 3 analiti PK di U3-1402 in soggetti affetti da CRC avanzato o metastatico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must satisfy all of the following criteria to be included in the
    study:
    1. Sign and date the ICF prior to the start of any study-specific qualification procedures.
    2. Male or female subjects =18 years (follow local regulatory requirements if the legal age of consent for study participation is >18
    years old).
    3. Pathological or histological confirmation and documentation of colon or rectum adenocarcinoma with advanced or metastatic disease.
    4. Must be resistant, refractory, or intolerant to at least 2 prior lines of therapy, that must include all of the following agents:
    a. Fluoropyrimidine
    b. Irinotecan
    c. Platinum agents (eg, oxaliplatin)
    d. An anti-EGFR agent, if clinically indicated (eg, RAS/BRAF wildtype)
    e. An anti-VEGF agent, unless contraindicated (eg, bevacizumab)
    5. Has at least 1 measurable lesion confirmed by BICR as per RECIST v1.1.
    6. Willing to provide required archival and pre-treatment tumor biopsy for assessment of HER3 expression levels by IHC and exploratory biomarkers, defined as:
    a. Pre-treatment tumor biopsy. Subjects may be exempted from the requirement to provide a pre-treatment tumor biopsy if archival tumor tissue was collected within 3 months of screening during or after treatment with the last prior cancer treatment and is of sufficient quantity (2 cores or 20 slides with adequate tumor tissue content).
    b. Archival tissue must be available and of sufficient quantity, as defined above, at the time of screening. If archival tissue is not available, a subject may be included provided the pre-treatment tumor biopsy is obtained and after discussion and agreement from Sponsor (Medical Monitor or designee). c. Consent to provide on-study tumor biopsy. When at least 10 on-study tumor biopsies per cohort have been collected, the Sponsor will provide written notification of a change to the requirement.
    7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
    8. Life expectancy =3 months.
    9. Has adequate bone marrow reserve and organ function, based on local
    laboratory data, defined as within 14 days prior to Cycle 1 Day 1
    I soggetti devono soddisfare tutti i seguenti criteri di per essere inclusi nello studio:
    1. Consenso informato scritto da parte del soggetto prima di sottoporsi a qualsiasi procedura specifica dello studio.
    2. Soggetti =18 anni (attenersi ai requisiti normativi locali se l'età legale per il consenso alla partecipazione allo studio è >18 anni).
    3. Conferma patologica/istologica di un adenocarcinoma del colon o del retto in fase avanzata o metastatica.
    4. Resistenza, refrattarietà o intolleranza ad almeno 2 linee precedenti di terapia sistemica, che devono includere tutti i seguenti agenti:
    a. Fluoropirimidina
    b. Irinotecan
    c. Agenti a base di platino (ad esempio, oxaliplatino)
    d. Un agente anti-EGFR, se indicato clinicamente (ad esempio, RAS/BRAF wildtype)
    e. Un agente anti-VEGF, salvo controindicazioni (ad esempio, bevacizumab)
    5. Presenza di almeno 1 lesione misurabile confermata con BICR secondo i Response Evaluation Criteria in Solid Tumors (RECIST) versione 1.1.
    6. Volontà di fornire una biopsia tumorale di archivio e una pretrattamento per la valutazione dei livelli di espressione di HER3 mediante analisi IHC e dei biomarcatori esplorativi, come di seguito definito:
    a. Biopsia tumorale pretrattamento. I soggetti possono essere esentati dall'obbligo di fornire una biopsia tumorale pretrattamento se il tessuto tumorale di archivio è stato prelevato entro 3 mesi dallo screening, durante o dopo la terapia con l'ultimo trattamento antitumorale precedente ed è in quantità sufficiente (2 agobiopsie o 20 vetrini con sufficiente contenuto di tessuto tumorale).
    b. Il tessuto di archivio deve essere disponibile e in quantità sufficiente, come sopra definita, al momento dello screening. In assenza di tessuto di archivio, un soggetto può essere incluso a condizione che sia ottenuta la biopsia tumorale pretrattamento e dopo averne discusso con lo Sponsor e averne ottenuto il consenso (monitor medico o incaricato).
    c. Consenso a fornire una biopsia tumorale durante lo studio. Quando saranno state acquisite almeno 10 biopsie tumorali per coorte durante lo studio, lo Sponsor invierà notifica scritta di modifica del requisito.
    7. Stato di validità dell'Eastern Cooperative Oncology Group (ECOG PS) pari a 0 o 1.
    8. Aspettativa di vita = 3 mesi.
    9. Al baseline presenza di una riserva di midollo osseo e funzionalità d'organo sufficienti, definite, sulla base dei dati del laboratorio locale nei 14 giorni precedenti al giorno 1 del ciclo 1
    E.4Principal exclusion criteria
    1. History of ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during screen.
    2. Clinically severe pulmonary compromise (based on PI's assessment) resulting from intercurrent pulmonary illnesses includ., but not limited to:
    a. any underlying pulmonary disorder (eg, pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion)
    b. any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)
    OR prior pneumonectomy.
    3. Is receiv. chronic systemic corticosteroids dosed at >10 mg prednisone or equiv. or any form of immunosuppr. therapy prior to Cycle 1 Day 1. Subj. who require use of bronchodilators, inhaled steroids, or local steroid injections may be included in the study.
    4. Evidence of leptomeningeal disease
    5. Has clinically active spinal cord compression or brain metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subj. with clinically inactive brain metastases may be included in the study. Subj. with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effects of radiotherapy.
    6. Inadequate washout period prior to Cycle 1 Day 1 of U3-1402:
    a. Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days;
    b. Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s) from a previous cancer treatment regimen or clinical study <14 days or 5 half-lives, whichever is longer;
    c. Immune checkpoint inhibitor therapy <21 days;
    d. Major surgery (excl. placement of vascular access) <4 weeks;
    e. Radiotherapy treatment to >30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 d;
    f. Chloroquine or hydroxychloroquine =14 days.
    7. Prior treat. with an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is any topoisomerase I inhibitor (eg, trastuzumab deruxtecan).
    8. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade =1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor (Medical Monitor or designee).
    9. Had primary malignancies other than CRC within 3 years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ dis., or other solid tumors curatively treated.
    10. Uncontrolled or sign. cardiovascular dis. prior to Cycle 1 Day 1, including:
    a. QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation interval of >470 milliseconds (ms) for females and >450 ms for males within 28 days;
    b. Left ventricular ejection fraction (LVEF) <50% by either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within 28 days;
    c. Uncont. hypertension (resting systolic blood press. >180 mmHg or diastolic blood press. >110 mmHg) within 28 days;
    d. Myocardial infarction within 6 months;
    e. NYHA Classes 2 to 4 within 28 days;
    f. Uncontrolled angina pectoris within 6 mths;
    g. Cardiac arrhythmia requiring antiarrhythmic treatment within 28 days.
    11. Known Hep. B and/or Hep. C infection, such as those with serologic evidence of viral infec. within 28 days of Cycle 1 Day 1.
    12. Any evidence of severe or uncontroll. systemic diseases
    1 Anamnesi di malattia polm. interstiziale (tra cui fibrosi polm. o polmonite da radiazioni), pneumopatia interstiziale (ILD) in atto, o sospetto della malattia suggerito da immagini acquisite durante lo screen.
    2 Compromiss. polmonare clinicamente grave (in base alla valutazione del PI) derivante da pneumopatie intercorrenti, tra cui anche:
    a. disturbi polmonari sottostanti (es. embolia polmonare, asma grave, broncopneumopatia cronica ostruttiva grave, malattia polmonare restrittiva, versamento pleurico)
    b. disturbi autoimmuni, del tessuto connettivo o infiammat. con interessamento polmonare (es. artrite reumatoide, sindrome di Sjögren, sarcoidosi)
    OPP. Preced. pneumonectomia.
    3 Trattam. cronico con corticosteroidi sistemici, dosati a >10 mg di prednisone o equivalente o qualsiasi forma di terapia immunosoppressiva prec. al giorno 1 del ciclo 1. I sogg che richiedono l'uso di broncodilatatori, steroidi per inalazione o iniezioni locali di steroidi possono essere inclusi nello studio.
    4 Evidenza di malattia leptomeningea
    5 Compress del midollo spinale o metastasi cerebrali clinic. attive, definite come non trattate e sintomatiche, o che richiedono la terapia con corticosteroidi o anticonvulsivanti per controllare i sintomi associati. I sogg. con metastasi cerebrali clinic. inattive possono ess. inclusi nello studio. I sogg. con metastasi cerebrali trattate, che non sono più sintomatici, e che non richied. success. tratt. con corticosteroidi o anticonvulsivanti, possono ess. inclusi nello studio se si sono ripresi dagli effetti tossici acuti della radioter.
    6 Periodo di sospensione insuff. prima del g 1 del ciclo 1 di U3-1402:
    a.Radioterapia panencefalica <14 gg o radioterapia cerebrale stereotattica <7 gg;
    b.Chemioterapia citotossica, agente sperimentale o altro(i) farmaco(i) antitumorale(i) da prece. regime di trattam. antitum. o studio clinico <14 gg o 5 emivite, qualunque sia maggiore;
    c.Terapia con inibitore del checkpoint immunitario <21 gg;
    d.Intervento chirurg. import. (escl. Posizion. di accesso vascolare) <4 sett.;
    e.Radioterapia con irradiazione di >30% del midollo osseo o con un'ampia area sottoposta a radiazioni <28 gg o radioterapia palliativa <14 gg;
    f.Clorochina o idrossiclorochina =14 gg.
    7 Preced. trattam. con un anticorpo anti-HER3 e/o un coniugato farmaco-anticorpo (ADC) che consiste in un derivato di exatecan inibitore della topoisomerasi I (es. trastuzumab deruxtecan).
    8 Tossicità non risolte da preced. terapie antitumorali, definite come tossicità (diverse dall'alopecia) non ancora risolte al grado =1 dei CTCAE-NCI v 5.0 o al baseline. I sogg. con tossicità croniche di grado 2 possono essere idonei a discrezione del PI, previa consultazione con lo Sponsor (monitor medico o incaricato).
    9 Tumori maligni primari diversi dal CRC nei 3 anni precedenti, ad eccez. di tumori cutanei non melanomatosi adeguat. escissi, malattia in situ sottoposta a terapia curativa o altri tumori solidi sottoposti a terapia curativa.
    10 Malattia cardiovascolare non controllata o signif. prima del giorno 1 del ciclo 1, tra cui:
    a)Prolungamento dell'intervallo QT corretto per la frequenza cardiaca con formula di Fridericia (QTcF) >470 millisecondi (ms) per le donne e >450 ms per gli uomini nei 28 gg preced;
    b)Frazione di eiezione ventricolare sinistra (LVEF) <50% misurata con ecocardiogramma (ECO) o angiocardioscintigrafia all'equilibrio (MUGA) nei 28 gg prec.;
    c)Ipertensione non controllata (pressione arteriosa sistolica a riposo > 180 mmHg o pressione arteriosa diastolica > 110 mmHg) nei 28 gg prec;
    d)Infarto del miocardio negli ultimi 6 mesi;
    e)Insuff. cardiaca congestizia delle classi da II a IV della NYHA nei 28 gg prec.;
    f)Angina pectoris non controll. negli ultimi 6 mesi;
    g)Aritmia cardiaca che richiede tratt. antiaritmico negli ultimi 28 gg.
    11 Infez. da epatite B e/o epatite C nota, es. con evidenza sierologica di infezione virale nei 28 gg prima del giorno 1 del ciclo 1.
    12 Qls evidenza di malattia grave o non controllata
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) is defined as the proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).
    ORR è definito come la percentuale di pazienti che raggiungono una migliore risposta complessiva (BOR) in termini di risposta completa (CR) o risposta parziale (PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data are collected at baseline, then from the start of study treatment until disease progression or other protocol defined reason. Tumor response as assessed by BICR per RECIST v1.1.
    I dati sono acquisiti al baseline, e successivamente dall'inizio del trattamento in studio fino a progressione della malattia o altra ragione specificata nel protocollo. Risposta del tumore valutata con BICR secondo i criteri RECIST v1.1
    E.5.2Secondary end point(s)
    Duration of Response (DoR) is defined as the time from the first documented response (complete response [CR] or partial response [PR]) to the date of disease progression or death due to any cause.
    Objective Response Rate (ORR) is defined as the proportion of subjects with a best overall response (BOR) of confirmed CR or PR.
    Duration of Response (DoR) is defined as the duration from the first documented response to the date of disease progression or death due to
    any cause.
    Disease Control Rate (DCR) is defined as the proportion of subjects who achieved a confirmed BOR of CR, PR, or stable disease (SD).
    Time to Tumor Response (TTR) is defined as the time from the start of study treatment to the date of the first documentation of objective response (CR or PR) that is subsequently confirmed.
    response (CR or PR) that is subsequently confirmed.
    Progression-Free Survival (PFS) is defined as the duration from the start of study treatment to the date of the first documentation of objective
    progressive disease (PD) or death due to any cause, whichever is earlier.
    Overall Survival (OS) is defined as the time from the start of study treatment to the date of death due to any cause.
    Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) (ILD
    and elevation of aminotransferases and TBL), ECOG PS, vital sign measurements, standard clinical laboratory parameters. AEs will be coded using the most recent version of MedDRA and will be graded using NCI-CTCAE v5.0. HER3 protein expression in tumor tissue (as determined by IHC) and correlation with efficacy Immunogenicity will be assessed through characterization of incidence and titer of ADAs in serum via a validated assay.
    PK endpoints: Cmax, Tmax, Ctrough, AUClast, and AUCtau
    La DoR è definita come l'intervallo di tempo dalla prima risposta documentata (CR o PR) alla data della progressione della malattia o del decesso per qualsiasi causa.
    L'ORR è definito come la percentuale di soggetti con una BOR in termini di CR o PR confermate.
    La DoR è definita come l'intervallo di tempo dalla prima risposta documentata alla data della progressione della malattia o del decesso per qualsiasi causa.
    Il DCR è definito come la percentuale di pazienti che raggiungono una BOR confermata in termini di CR, PR o SD.
    Il TTR è definito come l'intervallo di tempo compreso tra l'inizio del trattamento in studio e la data della prima documentazione di una risposta obiettiva (CR o PR) successivamente confermata.
    La PFS è definita come l'intervallo di tempo tra l'inizio del trattamento in studio e la data della prima documentazione di una PD obiettiva, o del decesso dovuto a qualsiasi causa, qualunque avvenga prima.
    L'OS è definita come l'intervallo di tempo che intercorre tra l'inizio del trattamento in studio e la data del decesso per qualsiasi causa.
    Incidenza di TEAE, SAE, AESI (ILD, incremento di aminotransferasi e TBL), stato di validità ECOG, misurazione dei parametri vitali, parametri clinici di laboratorio standard. Gli AE saranno codificati utilizzando la versione più recente del MedDRA e classificati secondo i CTCAE versione 5.0 dell'NCI.
    Espressione della proteina HER3 nel tessuto tumorale (determinata mediante IHC) e correlazione con l'efficacia
    L'immunogenicità sarà valutata mediante la caratterizzazione dell'incidenza e del titolo di ADA nel siero mediante test validato.
    endpoint di PK: Cmax, Tmax, Ctrough, AUClast, e AUCtau
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data are collected at baseline, then from the start of study treatment until disease progression or other protocol defined reason. Tumor response as assessed by BICR per RECIST v1.1 and death date reported by investigator. Death date is collected until the subject discontinues the study.
    I dati sono acquisiti al baseline, e successivamente dall'inizio del trattamento in studio fino a progressione della malattia o altra ragione specificata nel protocollo.
    La data del decesso è acquisita finché il soggetto non interrompe lo studio.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 Yes
    E.8.2.3.1Comparator description
    the overall tumor burden at baseline will be used as the comparator. Please see protocol section 13.
    the overall tumor burden at baseline will be used as the comparator. Please see protocol section 13.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Japan
    United States
    Belgium
    France
    Italy
    Poland
    Spain
    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
    LVLS
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    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)
    Subjects will be treated with the best treatment option at the investigator's decision
    I soggetti saranno trattati con l'opzione di trattamento migliore secondo la decisione dello Sperimentatore
    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 Decision2020-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
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