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    Summary
    EudraCT Number:2022-003786-38
    Sponsor's Protocol Code Number:IRST100.59
    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:2022-11-29
    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 number2022-003786-38
    A.3Full title of the trial
    68Ga-FAPI-46 PET-CT for molecular assessment of fibroblast activation and risk assessment in solid tumors
    68Ga-FAPI-46 PET/CT per la valutazione molecolare dell’attivazione dei fibroblasti e valutazione del rischio nei tumori solidi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic PET/CT (Positron Emission Tomography/Computed Tomography) examination with the radiotracer 68Ga-FAPI-46 to assess fibroblast activation and risk in solid tumors
    Esame diagnostico PET/CT (Tomografia a Emissione di Positroni/Tomografia computerizzata) con il radiotracciante 68Ga-FAPI-46 per valutare l’attivazione dei fibroblasti e il rischio nei tumori solidi
    A.3.2Name or abbreviated title of the trial where available
    FAPI Basket
    FAPI Basket
    A.4.1Sponsor's protocol code numberIRST100.59
    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 SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS IRST
    B.5.2Functional name of contact pointCentro di Coordinamento studi IRST
    B.5.3 Address:
    B.5.3.1Street Addressvia P. Maroncelli 40
    B.5.3.2Town/ cityMeldola (FC)
    B.5.3.3Post code47014
    B.5.3.4CountryItaly
    B.5.4Telephone number0544287167
    B.5.6E-mailcc.ubsc@irst.emr.it
    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 name68Ga-FAPI-46_IRSTIRCCS
    D.3.2Product code [68Ga-FAPI-46_IRSTIRCCS]
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.2Current sponsor code68Ga-FAPI-46_IRSTIRCCS
    D.3.9.4EV Substance CodePRD10041700
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 200
    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 Yes
    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
    Solid tumors
    Tumori solidi
    E.1.1.1Medical condition in easily understood language
    Patients affected by solid tumors
    Pazienti affetti da tumori solidi
    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 SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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
    The primary objective of this study is to evaluate the sensitivity of 68Ga-FAPI-46 PET/CT defined as the ratio between the number of 68Ga-FAPI-46 PET/CT positive patients and the number of patients with solid tumors presenting with FDG PET/CT scan dubious or inconclusive.
    Valutare la sensibilità dell’esame PET/CT con 68Ga-FAPI-46, definita come il rapporto tra il numero di pazienti 68Ga-FAPI-46 PET/CT positivi e il numero di pazienti con tumori solidi che presentano un esito dubbio o inconcludente all’esame PET/CT con 18F-FDG.
    E.2.2Secondary objectives of the trial
    68Ga-FAPI-46 PET/CT sensitivity by tumor histotype
    68Ga-FAPI-46 PET/CT sensitivity by lesion site
    Safety
    Description of 68Ga-FAPI-46 uptake
    Exploratory Objective: Description of 68Ga-FAPI-46 uptake after immunotherapy or other therapy
    Sensibilità della 68Ga-FAPI-46 PET/CT per istotipo tumorale
    Sensibilità della 68Ga-FAPI-46 PET/CT in base al sito della lesione
    Sicurezza
    Descrizione della captazione di 68Ga-FAPI-46
    Obiettivo esplorativo: Descrizione della captazione di 68Ga-FAPI-46 dopo immunoterapia o altre terapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have histologically or cytologically solid tumors at any stage
    2. 18F-FDG PET/CT scan dubious or inconclusive
    3. Male or Female, aged>18 years
    4. ECOG performance status <2
    5. If female of childbearing potential highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”, (2014_09_15 section 4.1) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing at least 6 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months.
    6. Participant is willing and able to give informed consent for participation in the study.
    1. I pazienti devono avere tumori con diagnosi istologica o citologica confermata, in qualsiasi stadio.
    2. Scansione 18F-FDG PET/CT dubbia o non conclusiva
    3. Maschio o femmina, di età superiore a 18 anni
    4. Performance status ECOG <2
    5. Se donna con potenziale fertile, sono obbligatori metodi anticoncezionali altamente efficaci, secondo la linea guida "Raccomandazioni relative alla contraccezione e al test di gravidanza negli studi clinici" (2014_09_15 sezione 4.1). Sono richiesti metodi anticoncezionali altamente efficaci a partire dalla visita di screening e per almeno 6 mesi dopo l'ultimo trattamento con il farmaco in studio. Test di gravidanza sierico negativo per le donne in età fertile entro 14 giorni dall'inizio del trattamento. Il paziente di sesso maschile e la sua partner di sesso femminile con potenziale fertile devono utilizzare 2 metodi di controllo delle nascite accettabili (1 dei quali deve includere un preservativo come metodo contraccettivo di barriera) a partire dallo screening e continuando per tutto il periodo di studio e per 6 mesi dopo l'ultima somministrazione del farmaco in studio. Due metodi accettabili di controllo delle nascite includono quindi il preservativo (metodo contraccettivo di barriera) e uno dei seguenti requisiti (uso consolidato di un metodo contraccettivo ormonale orale o iniettato o impiantato da parte del partner femminile; posizionamento di un dispositivo intrauterino (IUD) o di un sistema intrauterino (IUS) da parte del partner femminile; metodo di barriera aggiuntivo come un cappuccio occlusivo con schiuma/gel/film/crema/supposta spermicida nel partner femminile; legatura delle tube nel partner femminile; vasectomia o altra procedura che comporti infertilità (ad es, orchiectomia bilaterale), per più di 6 mesi.
    6. Il partecipante è disposto e in grado di dare il consenso informato per la partecipazione allo studio.
    E.4Principal exclusion criteria
    1. Participation in another clinical trial with any investigational agents within 30 days prior to study entry.
    2. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent
    3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to FAPI or other agents used in the study.
    4. Inability to remain still for the entire duration of the exam
    5. Pregnancy and lactation
    1. Partecipazione a un'altra sperimentazione clinica con qualsiasi agente sperimentale entro 30 giorni prima dell'ingresso nello studio.
    2. Condizioni mediche o psicologiche che non consentirebbero al partecipante di comprendere o firmare il consenso informato
    3. Storia di reazioni allergiche attribuite a composti di composizione chimica o biologica simile a FAPI o altri agenti utilizzati nello studio.
    4. Impossibilità di rimanere fermi per tutta la durata dell'esame
    5. Gravidanza e allattamento
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the evaluation of the detection rate of 68Ga-FAPI-46 PET/CT, defined as the proportion of FAPI- positive patients and the total number of recruited patients. A positive patient is defined as a patient with at least one FAPI-positive lesion.
    L'endpoint primario è la proporzione di pazienti FAPI-positivi rispetto al numero totale di pazienti reclutati. Un paziente positivo è definito come un paziente con almeno una lesione FAPI-positiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    E.5.2Secondary end point(s)
    Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each tumor histology. The results of visually interpreted PET/CT images will be compared with histopathological findings (from biopsy or surgery, whenever possible) or follow-up clinical data as the standard; Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each lesion site and proportion of 68Ga-FAPI-46 PET/CT-positive lesions over the total number of lesions for each lesion site; 68Ga-FAPI-46 uptake in terms of SUV; Safety defined as the number and percentage of patients undergoing grade 1 to 4 adverse events according to CTCAE version 5.0 until 30 days post 68Ga-FAPI-46 PET/CT.; 68Ga-FAPI-46 uptake after immunotherapy or other therapies in terms of SUV
    Proporzione di pazienti PET/CT positivi per 68Ga-FAPI-46 rispetto al numero totale di pazienti sottoposti a PET/CT per 68Ga-FAPI-46 per ogni istologia tumorale. I risultati delle immagini PET/TC interpretate visivamente saranno confrontati con i risultati istopatologici (da biopsia o intervento chirurgico, quando possibile) o con i dati clinici di follow-up come standard; Proporzione di pazienti PET/CT positivi per 68Ga-FAPI-46 rispetto al numero totale di pazienti sottoposti a PET/CT con 68Ga-FAPI-46 per ciascun sito di lesione e percentuale di lesioni PET/CT positive per 68Ga-FAPI-46 rispetto al numero totale di lesioni per ogni sede della lesione; Uptake di 68Ga-FAPI-46 in termini di SUV; Safety definita come il numero e la percentuale di pazienti sottoposti a eventi avversi di grado da 1 a 4 secondo CTCAE versione 5.0 fino a 30 giorni dopo 68Ga-FAPI-46 PET/CT.; Uptake di 68Ga-FAPI-46 dopo immunoterapia o altre terapie in termini di SUV
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months; 30 months; 30 months; 30 months; 30 months
    30 mesi; 30 mesi; 30 mesi; 30 mesi; 30 mesi
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 Yes
    E.8.1.7.1Other trial design description
    Studio diagnostico
    DIagnostic study
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    The end of trial will be the date of last data capture that is 30 days after last patient has undergone 68Ga-FAPI-46 PET/CT.
    La fine dello studio corrisponde alla data dell'ultima acquisizione dei dati, ovvero 30 giorni dopo che l'ultimo paziente è stato sottoposto a 68Ga-FAPI-46 PET/CT.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    A follow-up period of 30 days is provided after the svologation of the examination
    E' previsto un periodo di follow-up di 30 giorni dopo lo svologimento dell'esame
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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