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    Summary
    EudraCT Number:2021-003091-14
    Sponsor's Protocol Code Number:AB-106-G208
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-09-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003091-14
    A.3Full title of the trial
    A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors
    Studio di fase 2, multicentrico, in aperto, a braccio singolo per valutare l’efficacia e la sicurezza di taletrectinib in pazienti con NSCLC positivo per ROS1 e altri tumori solidi in stadio avanzato o metastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the effect of Taletrectinib in patients with advanced ROS1 Positive non- small cell lung cancer and Other Solid Tumors
    Studio di fase 2, multicentrico, in aperto, a braccio singolo per valutare l’efficacia e la sicurezza di taletrectinib in pazienti con NSCLC positivo per ROS1 e altri tumori solidi in stadio avanzato o metastatico.
    A.3.2Name or abbreviated title of the trial where available
    Taletrectinib in ROS1 Positive Lung Cancer Phase 2 Global Study (TRUST II)
    Studio per valutare l'effetto di Taletrectinib in pazienti con carcinoma polmonare non a piccole cel
    A.4.1Sponsor's protocol code numberAB-106-G208
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04919811
    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 SponsorAnHeart Therapeutics 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 supportAnHeart Therapeutics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnHeart Therapeutics
    B.5.2Functional name of contact pointPublic Relations
    B.5.3 Address:
    B.5.3.1Street Address777 Third Ave, Suite 1704
    B.5.3.2Town/ cityNY
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number9173883387
    B.5.5Fax number5163641845
    B.5.6E-mailpr@anhearttherapeutics.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 nameTaletrectinib
    D.3.2Product code [AB-106 / DS-6051b]
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAB-106
    D.3.9.3Other descriptive nameDS-6051b
    D.3.9.4EV Substance CodeSUB218609
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) No
    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 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 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
    Cancro polmonare non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cancro ai polmoni
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of taletrectinib by the objective response rate (ORR) in the patients with advanced or metastatic ROS1 positive NSCLC
    Valutare l'efficacia di taletrectinib in base al tasso di risposta obiettiva (ORR) nei pazienti con NSCLC ROS1 positivo avanzato o metastatico
    E.2.2Secondary objectives of the trial
    Efficacy Objectives:
    1. To evaluate the efficacy by duration of response (DOR)
    2. To evaluate the efficacy by progression-free survival (PFS)
    3. To evaluate the efficacy by time to failure(TTF)
    4. To evaluate the efficacy by time to response(TTR)
    5. To evaluate the efficacy by overall survival(OS)
    6. To evaluate the efficacy endpoints (ORR,DOR and PFS) assessed by investigators
    7. To evaluate the intracranial efficacy of taletrectinib

    Safety Objective:
    • To evaluate the safety and tolerability of taletrectinib

    Pharmacokinetics (PK) Objective:
    • To evaluate pharmacokinetic profile of taletrectinib
    Obiettivi di efficacia:
    1. Valutare l'efficacia in base alla durata della risposta (DOR)
    2. Valutare l'efficacia mediante la sopravvivenza libera da progressione (PFS)
    3. Valutare l'efficacia in base al tempo al fallimento (TTF)
    4. Valutare l'efficacia in base al tempo di risposta (TTR)
    5. Valutare l'efficacia in base alla sopravvivenza globale (OS)
    6. Valutare gli endpoint di efficacia (ORR,DOR e PFS) valutati dagli sperimentatori
    7. Valutare l'efficacia intracranica di taletrectinib

    Obiettivo di sicurezza:
    • Valutare la sicurezza e la tollerabilità di taletrectinib

    Obiettivo di farmacocinetica (PK):
    • Valutare il profilo farmacocinetico di taletrectinib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient age =18 years (or =20 years as required by local regulations
    2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC (cohorts 1-3) or other solid tumors (cohort 4).
    3. Evidence of ROS1 fusion in tumor tissue determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified or locally equivalent diagnostic laboratories. The molecular assays (ie RT-PCR, NGS) are highly recommended.
    4. Sufficient tumor tissue is required for performing confirmatory ROS1 fusion testing at the designated central laboratories. For patients in cohort 1, an archival tumor tissue specimen should be available and collected prior to enrollment. If archival tumor tissue is unavailable, then a fresh biopsy must be performed. For patients in cohort 2, a fresh biopsy for tumor tissue is highly recommended before enrollment even if the archival tumor tissue is available. For patients in cohorts 3 and 4, either an archival tumor tissue or a fresh tumor tissue must be available before enrollment.
    5. Patients with central nervous system (CNS) involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously treated and controlled, are allowed; the use of seizure prophylaxis is allowed as long as patients are taking non enzyme-inducing anti-epileptic drugs (non-EIAEDs). If corticosteroid treatment is required, it should be on stable or decreasing dose of =10 mg prednisone or equivalent. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment at least 14 days before enrollment and be clinically stable.
    6. The patient is either ROS1 TKI treatment naïve, or treated with prior ROS1 TKI(s):
    • Cohort 1: Systemic chemotherapy naïve or pretreated with one prior line of chemotherapy,
    but never treated with any ROS1 TKI;
    • Cohort 2: Prior treatment with one ROS1 TKI (crizotinib or entrectinib) and disease progression. The subject could be either chemotherapy naïve or has received one line of platinum and/or pemetrexed-based chemotherapy for the locally advanced or metastatic NSCLC.
    • Cohort 3: Prior treatment with = 2 ROS1 TKIs and disease progression. The subject could be either chemotherapy naïve or has received = 2 lines of platinum and/ or pemetrexed based chemotherapy for the locally advanced or metastatic NSCLC.
    • Cohort 4: Systemic chemotherapy naïve or pretreated with = 2 prior lines of chemotherapy, but never treated with any ROS1 TKI. ROS1 positive solid tumor types other than NSCLC will be enrolled.
    7. At least one measurable disease per RECIST 1.1 assessed by investigators.
    8. Eastern Cooperative Oncology Group Performance Status: 0 or 1.
    9. Patient with a life expectancy =12 weeks based on the judgement of investigators.
    10. Patients with adequate organ function meeting the following criteria:
    a) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): = 3.0 × upper limit of normal (ULN) (or = 5.0 × ULN, for patients with concurrent liver metastases);
    b) Serum total bilirubin: = 1.5 × ULN;
    c) Absolute neutrophil count: =1,500/µL;
    d) Platelet count: =100,000/µL;
    e) Hemoglobin: = 9.0 g/dL;
    f) Serum creatinine = 1.5 x ULN and estimated creatinine clearance (CLcr) =45 mL/min as
    calculated using the method standard for the institution (eg. Cockcroft - Gault Equation)
    11. Males and/or females who meet any of the following criteria
    12. For all females of childbearing potential, a negative pregnancy test must be obtained within 7 days of initial administration. Female patients of non-childbearing potential must meet at least 1 of the following criteria
    Full list in Protocol
    1. Età del paziente =18 anni (o =20 anni come richiesto dalle normative locali
    2. Diagnosi confermata istologicamente o citologicamente di NSCLC localmente avanzato o metastatico (coorti 1-3) o altri tumori solidi (coorte 4).
    3. Evidenza della fusione di ROS1 nel tessuto tumorale determinata da un test convalidato eseguito in laboratori diagnostici certificati Clinical Laboratory Improvement Amendments (CLIA) o equivalenti a livello locale. I saggi molecolari (cioè RT-PCR, NGS) sono altamente raccomandati.
    4. È necessaria una quantità sufficiente di tessuto tumorale per eseguire il test di conferma della fusione ROS1 presso i laboratori centrali designati. Per i pazienti nella coorte 1, un campione di tessuto tumorale d'archivio dovrebbe essere disponibile e raccolto prima dell'arruolamento. Se il tessuto tumorale d'archivio non è disponibile, è necessario eseguire una nuova biopsia. Per i pazienti nella coorte 2, una nuova biopsia del tessuto tumorale è altamente raccomandata prima dell'arruolamento anche se il tessuto tumorale d'archivio è disponibile. Per i pazienti nelle coorti 3 e 4, prima dell'arruolamento deve essere disponibile un tessuto tumorale d'archivio o un tessuto tumorale fresco.
    5. Sono ammessi pazienti con coinvolgimento del sistema nervoso centrale (SNC), inclusa la carcinomatosi leptomeningea, che sia asintomatica o precedentemente trattata e controllata; l'uso della profilassi delle crisi è consentito purché i pazienti stiano assumendo farmaci antiepilettici non induttori enzimatici (non EIAED). Se è necessario un trattamento con corticosteroidi, deve essere somministrato a una dose stabile o decrescente di = 10 mg di prednisone o equivalente. Se i pazienti presentano sintomi o segni neurologici dovuti a metastasi del SNC, i pazienti devono completare il trattamento con radiazioni cerebrali o irradiazioni gamma-coltello almeno 14 giorni prima dell'arruolamento ed essere clinicamente stabili.
    6. Il paziente è naïve al trattamento con ROS1 TKI o è stato trattato con precedenti ROS1 TKI:
    • Coorte 1: chemioterapia sistemica naïve o pretrattata con una precedente linea di chemioterapia,
    ma mai trattato con alcun ROS1 TKI;
    • Coorte 2: trattamento precedente con un ROS1 TKI (crizotinib o entrectinib) e progressione della malattia. Il soggetto potrebbe essere naïve alla chemioterapia o aver ricevuto una linea di chemioterapia a base di platino e/o pemetrexed per il NSCLC localmente avanzato o metastatico.
    • Coorte 3: trattamento precedente con = 2 ROS1 TKI e progressione della malattia. Il soggetto potrebbe essere naïve alla chemioterapia o aver ricevuto = 2 linee di chemioterapia a base di platino e/o pemetrexed per il NSCLC localmente avanzato o metastatico.
    • Coorte 4: chemioterapia sistemica naïve o pretrattata con = 2 linee precedenti di chemioterapia, ma mai trattata con ROS1 TKI. Saranno arruolati tipi di tumore solido positivo per ROS1 diversi da NSCLC.
    7. Almeno una malattia misurabile per RECIST 1.1 valutata dagli sperimentatori.
    8. Performance Status del gruppo di oncologia cooperativa orientale: 0 o 1.
    9. Paziente con un'aspettativa di vita = 12 settimane in base al giudizio degli sperimentatori.
    10. Pazienti con funzionalità organica adeguata che soddisfano i seguenti criteri:
    a) aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT): = 3,0 × limite superiore della norma (ULN) (o = 5,0 × ULN, per i pazienti con metastasi epatiche concomitanti);
    b) Bilirubina totale sierica: = 1,5 × ULN;
    c) Conta assoluta dei neutrofili: =1.500/µL;
    d) Conta piastrinica: =100.000/µL;
    e) Emoglobina: = 9,0 g/dL;
    f) Creatinina sierica = 1,5 x ULN e clearance della creatinina stimata (CLcr) = 45 ml/min come
    calcolato utilizzando il metodo standard per l'istituto (es. Cockcroft - Gault Equation)
    Elenco completo in Protocollo
    E.4Principal exclusion criteria
    1. Treatment with other investigational agents or anticancer therapy within 2 weeks or 5 half-lives of the compound, whichever is longer) prior to study enrollment. In addition, no concurrent anticancer therapy is permitted.
    2. Previously treated with immuno-oncology (IO) including immune checkpoint inhibitors within 12 weeks before enrollment.
    3. Major surgery within 4 weeks prior to enrollment.
    4. Radiation therapy with a limited field for palliation within 1 week before study treatment.
    5. Adverse events due to prior therapy are unresolved to = CTCAE Grade 1 except for AEs not constituting a safety risk to the patient in the judgment of investigators.
    6. Patients with spinal cord compression caused by tumor and/or cancerous meningitis.
    7. History or evidence of interstitial fibrosis, interstitial lung disease or TKI-induced pneumonitis. (Excluding clinically insignificant or asymptomatic post-radiation pneumonitis)
    8. Any gastrointestinal disorders that may affect absorption of oral medications.
    9. Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), known human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS)-related illness.
    10. Clinically significant cardiovascular diseases within 3 months prior to the first dose of investigational drug: myocardial infarction, severe/unstable angina, coronary/peripheral endovascular treatment, heart failure or cerebrovascular disorder including transient ischemic attack.
    11. Ongoing cardiac dysrhythmias of = CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QT interval corrected for heart rate byFredericia’s formula (QTcF) >470 milliseconds, or symptomatic bradycardia <45 beats per minute.
    12. Pregnancy or lactation.
    13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5) inhibitors, or inducers or P-glycoprotein inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment.
    14. Administration of agents with potential QT interval prolonging effect within 14 days prior to first dose of study treatment and while on treatment.
    15. Patients with other severe medical or mental diseases in whom the risk is increased by the participation to the study or treatment with study treatment in the judgement of the Investigator.





    1. Trattamento con altri agenti sperimentali o terapia antitumorale entro 2 settimane o 5 emivite del composto, a seconda di quale sia il periodo più lungo) prima dell'arruolamento nello studio. Inoltre, non è consentita alcuna terapia antitumorale concomitante.
    2. Precedentemente trattato con immuno-oncologia (IO) compresi gli inibitori del checkpoint immunitario entro 12 settimane prima dell'arruolamento.
    3. Intervento chirurgico maggiore entro 4 settimane prima dell'iscrizione.
    4. Radioterapia con un campo limitato per palliazione entro 1 settimana prima del trattamento in studio.
    5. Gli eventi avversi dovuti a una terapia precedente non sono risolti a = CTCAE Grado 1 ad eccezione degli eventi avversi che non costituiscono un rischio per la sicurezza del paziente a giudizio degli sperimentatori.
    6. Pazienti con compressione del midollo spinale causata da tumore e/o meningite cancerosa.
    7. Storia o evidenza di fibrosi interstiziale, malattia polmonare interstiziale o polmonite indotta da TKI. (Esclusa la polmonite post-radiazioni clinicamente insignificante o asintomatica)
    8. Eventuali disturbi gastrointestinali che possono influenzare l'assorbimento dei farmaci per via orale.
    9. Infezione batterica, fungina o virale attiva e clinicamente significativa, inclusi il virus dell'epatite B (HBV), il virus dell'epatite C (HCV) o il coronavirus 2 (SARS-CoV-2) della sindrome respiratoria acuta grave, noto virus dell'immunodeficienza umana (HIV) e malattia correlata alla sindrome da immunodeficienza acquisita (AIDS).
    10. Malattie cardiovascolari clinicamente significative nei 3 mesi precedenti la prima dose del farmaco sperimentale: infarto del miocardio, angina grave/instabile, trattamento endovascolare coronarico/periferico, insufficienza cardiaca o disturbo cerebrovascolare incluso attacco ischemico transitorio.
    11. Aritmie cardiache in corso di = Grado 2 CTCAE, fibrillazione atriale non controllata di qualsiasi grado o intervallo QT corretto per frequenza cardiaca con la formula di Fredericia (QTcF) >470 millisecondi o bradicardia sintomatica <45 battiti al minuto.
    12. Gravidanza o allattamento.
    13. Uso di alimenti o farmaci noti come potenti inibitori o induttori del citocromo P450 3A4/5 (CYP3A4/5) o inibitori o induttori della P-glicoproteina entro 14 giorni prima della prima dose del trattamento in studio e durante il trattamento.
    14. Somministrazione di agenti con potenziale effetto di prolungamento dell'intervallo QT entro 14 giorni prima della prima dose del trattamento in studio e durante il trattamento.
    15. Pazienti con altre gravi malattie mediche o mentali in cui il rischio è aumentato dalla partecipazione allo studio o dal trattamento con trattamento in studio a giudizio dello Sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed ORR according to RECIST 1.1 assessed by IRC for cohorts 1-2.
    ORR confermato secondo RECIST 1.1 valutato da IRC per le coorti 1-2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the entire study period.
    Per tutto il periodo di studio.
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    1. DOR according to RECIST 1.1 assessed by IRC (cohorts 1-2)
    2. PFS according to RECIST 1.1 assessed by IRC (cohorts 1-2)
    3. TTF according to RECIST 1.1 assessed by IRC(cohorts 1-2)
    4. TTR according to RECIST 1.1 assessed by IRC(cohorts 1-2)
    5. Overall Survival (cohorts 1-2)
    6. ORR, DOR and PFS according to RECIST 1.1 assessed by investigators (cohorts 1-2)
    7. Confirmed intracranial (IC)-ORR, IC-DOR, IC-PFS and time to intracranial progression(TTiP) according to RECIST 1.1 assessed by IRC (cohorts 1-2)
    Safety Endpoints:
    • Adverse events (AEs), laboratory abnormalities, vital signs, ECG and ophthalmologic data (cohorts 1-4)
    PK Endpoints:
    • PK parameters (Cmax, Tmax, AUC0-8 and AUCt) of taletrectinib (free base form) on C1D1 and C1D15 for approximate 10 patients of each cohort with extensive PK sampling approach (cohorts 1-2)
    • PK concentrations of taletrectinib (free base form) for other patients via sparse PK sampling approach (cohorts 1-4)
    Endpoint di efficacia:
    1. DOR secondo RECIST 1.1 valutato da IRC (coorti 1-2)
    2. PFS secondo RECIST 1.1 valutata da IRC (coorti 1-2)
    3. TTF secondo RECIST 1.1 valutato da IRC (coorti 1-2)
    4. TTR secondo RECIST 1.1 valutato da IRC (coorti 1-2)
    5. Sopravvivenza generale (coorti 1-2)
    6. ORR, DOR e PFS secondo RECIST 1.1 valutati dagli sperimentatori (coorti 1-2)
    7. Confermato intracranico (IC)-ORR, IC-DOR, IC-PFS e tempo alla progressione intracranica (TTiP) secondo RECIST 1.1 valutato da IRC (coorti 1-2)
    Punti di sicurezza:
    • Eventi avversi (AE), anomalie di laboratorio, segni vitali, ECG e dati oftalmologici (coorti 1-4)
    Endpoint PK:
    • Parametri farmacocinetici (Cmax, Tmax, AUC0-8 e AUCt) di taletrectinib (forma base libera) su C1D1 e C1D15 per circa 10 pazienti di ciascuna coorte con approccio di campionamento farmacocinetico esteso (coorti 1-2)
    • Concentrazioni farmacocinetiche di taletrectinib (forma di base libera) per altri pazienti mediante un approccio di campionamento farmacocinetico sparso (coorti 1-4)
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Efficacy: Throughout the entire study period.
    •Safety: Adverse events (AEs) - Screening until Safety Follow up (30 days post last dose); laboratory abnormalities, vital signs, ECG - Screening until End of Treatment (EoT); and ophthalmologic data - Screening.
    •PK: C1D1, C1D8, C1D15, C2D1
    •Efficacia: durante l'intero periodo di studio.
    •Sicurezza: Eventi avversi (AE) - Screening fino al follow-up di sicurezza (30 giorni dopo l'ultima dose); anomalie di laboratorio, segni vitali, ECG - Screening fino alla fine del trattamento (EoT); e dati oftalmologici - Screening.
    •PK: C1D1, C1D8, C1D15, C2D1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    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 trial1
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    China
    Japan
    Korea, Republic of
    United States
    France
    Poland
    Spain
    Italy
    Ukraine
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 48
    F.4.2.2In the whole clinical trial 119
    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)
    If the patient withdraws from the study before disease progression, a tumor evaluation should be performed every 12 weeks after the last dose, until disease progression or a new anti-cancer therapy is commenced. Follow up for survival will continue until death, withdrawal of informed consent, loss of follow-up and termination of the study by the sponsor, whichever occurs first.
    Se il paziente si ritira dallo studio prima della progressione della malattia, deve essere eseguita una valutazione del tumore ogni 12 settimane dopo l'ultima dose, fino all'inizio della progressione della malattia o di una nuova terapia antitumorale. Il follow-up per la sopravvivenza continuerà fino alla morte, alla revoca del consenso informato, alla perdita del follow-up e alla conclusione dello studio da parte dello sponsor, a seconda di quale evento si verifica per primo.
    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 Decision2022-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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