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    Summary
    EudraCT Number:2022-001361-12
    Sponsor's Protocol Code Number:FG001-CT-003
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-07-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2022-001361-12
    A.3Full title of the trial
    An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) for localization of oral and oropharyngeal squamous cell carcinoma
    Et åbent, ikke- randomiseret, single center, single dosis eksplorativt fase II forsøg med FG001 (et stof til billeddannelse) til at lokalisere mund og svælg cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FG001 (an imaging agent) in patients with oral and oropharyngeal squamous cell carcinoma
    A.4.1Sponsor's protocol code numberFG001-CT-003
    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 SponsorFluoGuide A/S
    B.1.3.4CountryDenmark
    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 supportFluoGuide A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOzack ApS
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressOle Maaløes Vej 3
    B.5.3.2Town/ cityKøbenhavn N
    B.5.3.3Post code2200
    B.5.3.4CountryDenmark
    B.5.6E-mailack@ozack.dk
    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 nameFG001
    D.3.4Pharmaceutical form Lyophilisate for 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.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeFG001
    D.3.9.3Other descriptive nameFG001 sodium
    D.3.9.4EV Substance CodeSUB216035
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.2
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeuPAR binding peptide (AE105) attached to the fluorophore indocyanine green (ICG)
    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
    Oral and oropharyngeal squamous cell carcinoma
    E.1.1.1Medical condition in easily understood language
    Oral and oropharyngeal squamous cell carcinoma
    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 PT
    E.1.2Classification code 10041857
    E.1.2Term Squamous cell carcinoma of the oral cavity
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10031112
    E.1.2Term Oropharyngeal squamous cell carcinoma
    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
    • To evaluate FG001 for the detection of oral and oropharyngeal cancer
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacokinetics profile (PK) of single i.v dose of FG001
    • To evaluate safety and tolerability of FG001
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Naive subjects with primary biopsy-proven squamous cell carcinoma (with or without metastaseis) of the oral cavity or oropharynx eligible for resection of the primary tumor at the trial site
    2. The subjects can be scheduled for sentinel node biopsy (SNB) without ICG
    3. Subjects with a sub side oral or oropharyngeal cancer i.e., cancer re occurrence is in a new area
    4. Location of tumor suitable for imaging i.e., isolated/detached cancer where the subject can open the mouth for the tumor to be accessible
    5. Subjects aged 18 years or older
    6. Capable of understanding and giving written informed consent
    7. Subject must not previously have received the trial drug (FG001)
    8. Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit and avoid sperm donation during this period
    9. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)
    E.4Principal exclusion criteria
    1. Scheduled sentinel node biopsy (SNB) with ICG-based optical tracer
    2. Previous surgery, chemotherapy or radiotherapy to the oral cavity
    3. Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the drug product
    4. Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
    5. Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the Investigator
    6. Pre-existing hepatic and/or renal insufficiency
    o Estimated GFR (eGFR) < 45 ml/min/1.73m2
    o INR > 1.7
    If a subject is being treated with anticoagulants and the INR is borderline (1.8) and the PI judges the subject to be eligible with no safety concerns AND the CMO at FluoGuide agrees, such subject may be deemed eligible for the trial. This must be clearly documented in the medical journal and at FluoGuide.
    E.5 End points
    E.5.1Primary end point(s)
    • Sensitivity for detection of oral and oropharyngeal cancer verified by histology
    E.5.1.1Timepoint(s) of evaluation of this end point
    The efficacy of FG001 (as a tumor imaging agent) is examined by the sensitivity, which is verified via the intensity of fluorescence from the specimen taken post-surgery.
    E.5.2Secondary end point(s)
    a. Efficacy
    1. Tumor To Background Ratio, TBR: Signal intensity in tumor

    2. PK profile determined by non-compartmental analysis:
    • Peak plasma concentration (Cmax)
    • Time of peak plasme concentration (tmax)
    • Area under the plasma concentration-time curve from time-zero extrapolated to infinity (AUC0-inf)
    • Area under the plasma concentration-time curve from time-zero to last quantifiable concentration (AUC0-t)
    • Terminal half-life (t½)

    b. Safety and tolerability
    • Adverse Events
    • Laboratory parameters
    • 12 - lead ECG parameters
    • Vital Signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    TBR will be calculated as the fluorescence of the tumor relative to background tissue, as measured by near-infrared (NIR) imaging. This is imaged in situ during resection

    The PK profile will be determined for all included subjects undergoing surgery by obtaining 5 PK samples per subject during the trial, with first measurement at hour 1± 15 minutes post-injection and last at Hour 44 1± 6h (EoT)

    Safety and Tolerability will be evaluated from Baseline visit (Pre-surgery) until the EoT.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    Trial completion is defined as when the last enrolled subject (LPLV) has completed the final scheduled visit (EoT).
    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 months5
    E.8.9.1In the Member State concerned 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state32
    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)
    After surgery, each subject will be monitored until 44 hours post-injection of FG001 whereafter the subject will be discharged (EoT).
    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 Decision2022-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-10
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