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    Summary
    EudraCT Number:2021-001488-25
    Sponsor's Protocol Code Number:FHD-609-C-001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-19
    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 number2021-001488-25
    A.3Full title of the trial
    A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered FHD-609 in Subjects with Advanced Synovial Sarcoma
    Studio multicentrico, in aperto, di aumento progressivo e di espansione della dose, di fase I, volto a valutare la sicurezza, la tollerabilità, la farmacocinetica, la farmacodinamica e l'attività clinica di FHD-609 somministrato per via endovenosa in soggetti con sarcoma sinoviale avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to look at the safety and potential efficacy of FHD-609 in people with advanced synovial sarcoma
    Uno studio clinico per esaminare la sicurezza e la potenziale efficacia di FHD-609 nelle persone con sarcoma sinoviale avanzato
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberFHD-609-C-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04965753
    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 SponsorFoghorn 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 supportFoghorn Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFoghorn Therapeutics Inc.
    B.5.2Functional name of contact pointJacqueline Jean Cinicola
    B.5.3 Address:
    B.5.3.1Street Address500 Technology Square
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018886151298
    B.5.6E-mailinfo@foghorntx.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 name-
    D.3.2Product code [FHD-609]
    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 INNNA
    D.3.9.2Current sponsor codeFHD-609
    D.3.9.3Other descriptive nameFHT-11613
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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
    Advanced Synovial Sarcoma (SS)
    Sarcoma sinoviale Avanzato (SS)
    E.1.1.1Medical condition in easily understood language
    Synovial Sarcoma (SS)
    Sarcoma sinoviale (SS)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10042863
    E.1.2Term Synovial sarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To determine the safety and tolerability of FHD-609 when administered as an intravenous (IV) monotherapy in subjects with advanced synovial sarcoma (SS)
    • To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of FHD-609 in subjects with advanced SS
    - Determinare la sicurezza e la tollerabilità di FHD-609 somministrato come monoterapia endovenosa (EV) in soggetti con sarcoma sinoviale (SS) avanzato
    - Identificare la dose massima tollerata (MTD) e/o la dose raccomandata per la fase II (RP2D)
    di FHD-609 in soggetti con SS avanzato
    E.2.2Secondary objectives of the trial
    • To determine the pharmacokinetics (PK) of FHD-609 in plasma when administered as an IV monotherapy in subjects with advanced SS
    • To characterize the preliminary clinical activity associated with FHD-609 in subjects with advanced SS by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
    - Determinare la farmacocinetica (PK) di FHD-609 nel plasma dopo somministrazione come monoterapia EV in soggetti con SS avanzato
    - Caratterizzare l'attività clinica preliminare associata a FHD-609 in soggetti con SS avanzato mediante i criteri di valutazione della risposta nei tumori solidi (RECIST) versione 1.1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be >= 18 or >= 16 years of age with a minimum body weight of 50 kg.
    2. Subject must have a diagnosis of SS, defined by the presence of the SS18-SSX rearrangement, as confirmed by the Investigator (evidence from the diagnostic pathology of prior biopsy must be available). Subject must have advanced SS, which for the purposes of this study, is defined as any of the following:
    • Metastatic
    • Local (primary or recurrent), unresectable (with Investigator and Medical Monitor approval)
    Subject must have been treated with <= 4 regimens of systemic chemotherapies. Subjects who have undergone > 4 regimens of systemic chemotherapy may be permitted with Medical Monitor approval. Subjects must have:
    • Demonstrated progression of disease on their most recent therapy or
    • Discontinued their most recent therapy due to the potential for cumulative toxicity, intolerability or lack of continued clinical benefit, in the opinion of the Investigator.
    Eligible subjects with progression of disease on their most recent therapy may enroll in the Dose Escalation Phase and in Arm 1 of the Dose Expansion Phase. Eligible subjects with responsive and/or stable disease on their most recent therapy may enroll in the Dose Escalation Phase and in Arm 2 of the Dose Expansion Phase.
    3. Subject must have measurable disease by RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm with calipers and/or CT scan. Measurable lesions cannot have undergone any local treatment or radiation nor can any local treatment or radiation involving measurable lesions be anticipated.
    4. Subject or his/her parent or legal guardian (when applicable) must be able to understand and be willing to sign an informed consent and, when applicable, subject must sign assent form.
    5. Subject must be willing and able to comply with scheduled study visits and treatment plans.
    6. Subject must be willing to undergo all study procedures (biopsies at baseline, at least 1 on-treatment and at EOT [unless contraindicated due to medical risk; other exceptions to this are at the discretion of the Sponsor’s Medical Monitor]), laboratory testing, and imaging approximately every 8 (or 12) weeks independent of dose delays, interruptions, and/or reductions.
    7. Subject must have an ECOG PS of <= 2.
    • Arm 2 (Dose Expansion Phase): Subject must have an ECOG PS of <= 3
    8. Subject must have a life expectancy of >= 3 months.
    • Arm 2 (Dose Expansion Phase): Subject must have a life expectancy of >= 2 months
    9. Subject must have adequate venous access for IV drug administration and blood collection.

    Please refer to the protocol for full list of inclusion criteria.
    1. Il soggetto deve avere un'età >=18 anni o >= 16 anni con un peso corporeo minimo di 50 kg.
    2. Il soggetto deve avere una diagnosi di SS, definita dalla presenza del riarrangiamento SS18- SSX, confermata dallo sperimentatore (deve essere disponibile un'evidenza della patologia diagnostica di una precedente biopsia). Il soggetto deve presentare un SS avanzato che, per gli obiettivi di questo studio, è definito come:
    • Metastatico
    • Locale (primario o ricorrente), non resecabile (con l'approvazione dello sperimentatore e del supervisore medico)
    I soggetti devono essere stati trattati con <=4 regimi chemioterapici sistemici. I soggetti sottoposti a > 4 regimi chemioterapici sistemici possono essere accettati con l'approvazione del supervisore medico. I soggetti devono:
    • Presentare progressione dimostrata della malattia con la più recente terapia assunta
    oppure
    • Aver interrotto la terapia più recente a causa della possibile tossicità cumulativa, di intolleranza o mancanza di beneficio clinico continuativo, secondo il giudizio dello sperimentatore.
    I soggetti idonei che presentano progressione della malattia con la terapia più recente possono essere arruolati nella fase di aumento progressivo della dose e nel Braccio 1 della fase di espansione della dose. I soggetti idonei con malattia responsiva e/o stabile con la terapia più
    recente possono essere arruolati nella fase di aumento progressivo della dose e nel Braccio 2 della fase di espansione della dose.
    Nota: il criterio di inclusione 15 indica i requisiti temporali della terapia precedente. 3. Il soggetto deve presentare una malattia misurabile secondo RECIST v.1.1, definita come almeno una lesione che può essere misurata accuratamente in almeno una dimensione
    (diametro maggiore da registrare) >=10 mm misurata con calibri e/o TAC. Le lesioni bersaglio non devono essere state sottoposte ad alcun trattamento locale o radioterapia a meno che non siano progredite post-trattamento, né può essere previsto un qualsiasi trattamento locale o radioterapia che coinvolga le lesioni bersaglio.
    4. Il soggetto o il suo genitore o tutore legale (se applicabile) deve essere in grado di comprendere e accettare di firmare un consenso informato e, se applicabile, il soggetto deve firmare un modulo di assenso.
    5. Il soggetto deve accettare ed essere in grado di rispettare le visite programmate e i piani terapeutici dello studio.
    6. Il soggetto deve accettare di sottoporsi a tutte le procedure dello studio (biopsie al basale, almeno 1 durante il trattamento e all'EOT [a meno che non siano controindicate a causa di rischi di natura medica; altre eccezioni sono a discrezione del supervisore medico dello Sponsor]), ad analisi di laboratorio e agli esami di diagnostica per immagini all'incirca ogni 8 (o 12) settimane indipendentemente da ritardi, interruzioni e/o riduzioni della dose.
    7. Il soggetto deve presentare un PS ECOG <=2.
    • Braccio 2 (fase di espansione della dose): il soggetto deve presentare un PS ECOG <=3.
    8. Il soggetto deve avere un'aspettativa di vita >=3 mesi.
    Braccio 2 (fase di espansione della dose): il soggetto deve avere un'aspettativa di vita >=2
    mesi.
    9. Il soggetto deve presentare un accesso venoso adeguato per la somministrazione EV del farmaco e il prelievo di sangue.

    Per una lista completa dei criteri di inclusione si prega di fare riferimento al protocollo
    E.4Principal exclusion criteria
    1. Subject (or his/her parent or legal guardian, when applicable) is unable to provide informed consent (or assent, when applicable) and/or to follow protocol requirements.
    2. Subject has other malignancy which may interfere with the diagnosis and/or treatment of SS and/or interpretation of outcome results.
    3. Subject has an active severe infection requiring systemic therapy. Subject is permitted to enroll once any required antibiotic and/or antifungal therapy has been completed and/or infection is determined to be controlled.
    4. Subject has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections; subjects with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Subject has known positive human immunodeficiency virus (HIV) antibody results or acquired immunodeficiency syndrome (AIDS)-related illness; subjects with CD4+ T-cell counts = 350 cells/µL will be permitted, as will subjects who have not had an AIDS-related illness within the past 12 months.
    5. Subject has an uncontrolled concurrent medical disease and/or psychiatric illness/social situation that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol.
    6. Subject is receiving systemic steroid therapy for acute illness (stable doses for controlled chronic disease are permitted) or any other systemic immunosuppressive medication. Local steroid therapies (inhaled or topical steroids) are acceptable. See Exclusion criterion 7 for details on steroids in the setting of central nervous system (CNS) disease.
    7. Subjects with known CNS metastases are only permitted under the following conditions: Brain metastases must have been stable for the at least 2 months since completion of most recent CNS-directed intervention. Subject may be on corticosteroids so long as the dose is stable or decreasing at the time of study entry. Anti-epileptic therapy is allowed so long as medications are not otherwise excluded and seizures have been controlled for at least 4 weeks since the last anti-epileptic medication adjustment. Subjects with active brain metastases and/or leptomeningeal disease are excluded.
    • Dose Escalation Phase: Subjects with known CNS metastases that meet the above conditions are permitted to enroll in dose escalation.
    • Arm 1 (Dose Expansion Phase): Subjects with known or suspected CNS metastases are excluded from Arm 1.
    • Arm 2 (Dose Expansion Phase): Subjects with CNS metastases that meet the above conditions are permitted to enroll in Arm 2.
    8. Subject has known hypersensitivities to components of FHD-609.
    9. Subject has prior exposure to a BRD9 degrader.
    10. Subject is participating in any other clinical trials. Exceptions include participation in any observational or nontherapeutic clinical trials.
    1. Il soggetto (o genitore o tutore legale, se applicabile) non è in grado di fornire il consenso informato (o l'assenso, se applicabile) e/o di seguire i requisiti del protocollo.
    2. Il soggetto ha un'altra neoplasia che potrebbe interferire con la diagnosi e/o il trattamento dell'SS e/o con l'interpretazione dei risultati relativi all'esito.
    3. Il soggetto ha un'infezione severa attiva che richiede una terapia sistemica. Il soggetto può arruolarsi una volta completata la terapia antibiotica e/o antifungina richiesta e/o una volta che l'infezione è ritenuta controllata.
    Il soggetto ha un'infezione attiva da virus dell'epatite B (HBV) o dell'epatite C (HCV); i soggetti con una risposta virale sostenuta al trattamento anti HCV o con immunità a una precedente infezione da HBV saranno accettati. Il soggetto presenta risultati positivi noti per il virus dell’immunodeficienza umana (HIV) o per malattie correlate alla sindrome da immunodeficienza acquisita (AIDS); i soggetti con conte delle cellule T CD4+ =350 cellule/µL saranno accettati, così come i soggetti che non hanno avuto una malattia correlata all'AIDS negli ultimi 12 mesi.
    5. Il soggetto presenta una malattia concomitante non controllata e/o una malattia psichiatrica/una situazione sociale che, secondo il giudizio dello sperimentatore, potrebbe causare rischi inaccettabili per la sicurezza o compromettere l'adesione al protocollo.
    6. Il soggetto sta ricevendo una terapia sistemica con steroidi per una malattia acuta (sono permesse dosi stabili per una malattia cronica controllata) o qualsiasi altro farmaco immunosoppressore sistemico. Terapie locali con steroidi (inalatori o topici) sono accettabili. Vedere il criterio di esclusione 7 per dettagli sugli steroidi nel contesto di malattie del sistema nervoso centrale (SNC).
    7. I soggetti con metastasi note al SNC possono partecipare solo nelle seguenti condizioni: Le metastasi cerebrali devono essere stabili da almeno 2 mesi dopo il completamento dell'intervento più recente diretto al SNC. Il soggetto può assumere corticosteroidi se la dose è stabile o in via di riduzione al momento dell'ingresso nello studio. La terapia antiepilettica è permessa se i farmaci non sono esclusi per altri motivi e le convulsioni sono controllate da
    almeno 4 mesi dall'ultimo aggiustamento del farmaco antiepilettico. Sono esclusi i soggetti con metastasi cerebrali attive e/o malattia leptomeningea.
    • Fase di aumento progressivo della dose: i soggetti con metastasi note al SNC che soddisfano le condizioni di cui sopra possono essere arruolati nella fase di aumento progressivo della dose.
    • Braccio 1 (fase di espansione della dose): i soggetti con metastasi note o sospette al SNC sono esclusi dal Braccio 1.
    • Braccio 2 (fase di espansione della dose): i soggetti con metastasi note al SNC che soddisfano le condizioni di cui sopra possono essere arruolati nel Braccio 2.
    8. Il soggetto presenta un'ipersensibilità nota a componenti di FHD-609.
    9. Il soggetto è stato precedentemente esposto a una sostanza degradante la proteina 9 contenente un bromodominio (BRD9).
    10. Il soggetto sta partecipando ad altre sperimentazioni cliniche. Eccezioni includono la partecipazione a sperimentazioni cliniche osservazionali o non terapeutiche.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of treatment-emergent adverse events (TEAEs), adverse events (AEs), dose-limiting toxicities (DLTs), serious AEs (SAEs), and
    AEs leading to discontinuation; laboratory and other safety assessments
    Incidenza di eventi avversi emergenti dal trattamento (TEAE), eventi avversi (AE), tossicità dose-limitante (DLT), eventi avversi gravi (SAE) e
    eventi avversi che portano all'interruzione; valutazioni di laboratorio e altre valutazioni di sicurezza
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to the protocol.
    Si prega di fare riferimento al protocollo
    E.5.2Secondary end point(s)
    Plasma concentration versus time profiles of FHD-609 will be determined to characterize the pharmacokinetic parameters for FHD-609
    La concentrazione plasmatica versus i profili temporali di FHD-609 sarà determinata per caratterizzare i parametri farmacocinetici per FHD-609
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to the protocol.
    Si prega di fare riferimento al protocollo
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarkers assessment
    Tollerabilità, valutazione dei biomarcatori
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    Open
    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 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 EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA 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
    France
    Italy
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of study is defined as the time at which all subjects have discontinued treatment with FHD-609, have been followed for 2 years after the last dose for survival assessment or have died, been lost to follow-up, or withdrawn consent.
    La fine dello studio è definita come il momento in cui tutti i soggetti hanno interrotto il trattamento con FHD-609, sono stati seguiti per 2 anni dopo l'ultima dose per la valutazione della sopravvivenza o sono deceduti, sono stati persi al follow-up o hanno ritirato il consenso.
    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 months0
    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 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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    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 Decision2022-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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