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    Summary
    EudraCT Number:2020-003089-38
    Sponsor's Protocol Code Number:FG001-CT-001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-003089-38
    A.3Full title of the trial
    An open-label, dose escalation, single-dose administration, multi-center phase I/II trial of FG001 (an imaging agent), in patients with glioblastoma scheduled for neurosurgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-center trial of FG001 in patients with malignant brain tumour scheduled for neurosurgery.
    Multicenter forsøg för utprovning och utvärdering av ämnet FG001 hos patienter med misstänkt elakartad hjärntumör.
    A.4.1Sponsor's protocol code numberFG001-CT-001
    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 pointAnn Christine Korsgaard
    B.5.3 Address:
    B.5.3.1Street AddressOle Maaløes Vej 3
    B.5.3.2Town/ cityCopenhagen
    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.3.10 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Gliolan 30 mg/ml powder for oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderMedac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/02/121 (expired)
    D.3 Description of the IMP
    D.3.1Product name5-ALA
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.8INN - Proposed INN5-AMINOLEVULINIC ACID
    D.3.9.1CAS number 106-60-5
    D.3.9.2Current sponsor code5-ALA
    D.3.9.4EV Substance CodeSUB12853MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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
    E.1.1.1Medical condition in easily understood language
    Glioblastoma Multiforme
    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 10018337
    E.1.2Term Glioblastoma multiforme
    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
    Phase I:
    - To evaluate the safety and tolerability of single i.v. doses of FG001 in patients with GBM scheduled for surgery
    - To establish the optimal dose for imaging of FG001 in patients with GBM

    Phase II:
    - To evaluate the efficacy of FG001 in patients with malignant glioma undergoing surgery and to compare it with the efficacy of 5-ALA in patients with malignant glioma undergoing surgery
    E.2.2Secondary objectives of the trial
    Phase I:
    - To determine the pharmacokinetics (PK) profile of single i.v. doses of FG001
    - To evaluate the efficacy of FG001 in patients with GBM scheduled for surgery

    Phase II:
    - To determine the PK profile of single i.v. doses of FG001
    - To evaluate the efficacy of FG001 or 5-ALA after surgery by determination of gross total resection (GTR)
    - Positive Predicted Value (PPV) of FG001 and 5-ALA fluorescence tumor tissue obtained from each trial patient
    - To evaluate the contrast of FG001 for the surgeon to differentiate tumor tissue from normal tissue
    - Evaluate the NPV from each trial patient of FG001 and compare with 5-ALA
    - To evaluate the safety and tolerability of the optimal i.v. dose of FG001 in patients with malignant glioma scheduled for surgery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients diagnosed with tumor specific contrast enhancement on MRI suggestive of malignant glioblastoma - primary .
    2. Scheduled for neurosurgery with the objective to take biopsy, grading or remove cancer tissue
    3. Patients aged 18 years or older
    4. Capable of understanding and giving written informed consent
    5. 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)
    6. Male patients must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after the end-of-trial visit
    7. Patient must not previously have received the trial drug (FG001)
    8. Patients can only be included if the surgery is planned to be guided by 5-ALA.
    9. Patients can only be included if the scheduled surgery is anticipated gross total resection (GTR) with the objective to remove cancer tissue
    10. Patients must have normal organ and bone marrow function and be appropriate surgical candidates per site standard of care (SOC).
    E.4Principal exclusion criteria
    1. Any known allergy or hypersensitivity to indocyanine green (ICG)
    2. Female patients who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
    3. Overall performance status or co-morbidity deeming the patient unfitted for participation in the trial as judged by the Investigator
    4. Pre-existing hepatic and/or renal insufficiency
    - INR > 1,7
    - Estimated GFR (eGFR) <45 ml/min/1,73m2
    5. Unwilling or unable to follow the protocol requirements
    6. History of allergic reactions attributed to compounds of similar chemical/biologic composition to 5-ALA
    7. Known or documented personal or family history of porphyria
    8. Prior history of serious gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease
    9. Simultaneous participation in another clinical trial receiving a trial drug
    10. Simultaneous use of other potentially phototoxic substances (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing 5-ALA for 24 hours during the perioperative period.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    a. Safety and tolerability evaluated by:
    - Adverse events (AEs)
    - Laboratory parameters (Clinical chemistry)
    - 12-lead ECG parameters
    - Vital signs (including systolic and diastolic blood pressure, pulse, body temperature and respiratory rate)
    b. Establish optimal dose
    - Dose of FG001 giving the highest intra-operative tumor-to-background ratio (TBR)

    Phase II:
    - The proportion of patients with at least one indeterminated tissue or unexpected fluorescent tissue at the End of Surgery (EOS), where FG001- or 5-ALA-induced fluorescence is consistent with the histology
    E.5.1.1Timepoint(s) of evaluation of this end point
    Data will be collected from 1 hour and up to 48 hours from administration of FG001 (post-injection FG001)
    E.5.2Secondary end point(s)
    Phase I:
    a. Evaluation of sensitivity and specificity of FG001
    b. PK profile determined by non-compartmental analysis:
    - Peak plasma concentration (C max)
    - Area under the plasma concentration-time curve from time-zero extrapolated to infinity (AUC 0-inf)
    - Area under the plasma concentration-time curve from time-zero to last quantifiable concentration (AUC 0-t)
    - Terminal half-life (t ½)

    Phase II:
    a. PK profile determined by non-compartmental analysis:
    - Peak plasma concentration (Cmax)
    - 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. Determination of the percentage of patients with gross total resection by post-MRI scans guided by either FG001 or 5-ALA
    c. Positive Predicted Value (PPV) of FG001 and 5-ALA fluorescence of the single bulk tumor tissue obtained from each trial patient
    d. Negative Predictive Value (NPV) of FG001 and 5-ALA of biopsies obtained nearby fluoresence tumor areas from each trial patient
    e. Safety and tolerability evaluated by:
    - Adverse events
    - Laboratory parameters
    - 12-lead ECG parameters
    - Vital signs (including systolic and diastolic blood pressure, pulse, body temperature and respiratory rate)
    f. Evaluation of TBR values for FG001
    E.5.2.1Timepoint(s) of evaluation of this end point
    Data will be collected from 1 hour and up to 48 hours from administration of FG001 (post-injection FG001)
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Yes
    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 completion of this trial will be the date of the database hardlock of the clinical database.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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 patient is closely monitored up to 70 hours postinjection of FG001 and up to 48 post-administration of 5-ALA. The patient will be discharged at this point, which is defined as "End-of-Trial visit" (EoT) for the patient. If the PI judges it as necessary, a follow-up telephone call after EoT can be carried out according to the standard procedure at the hospital.
    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 Decision2021-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-12
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