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    Summary
    EudraCT Number:2017-001471-23
    Sponsor's Protocol Code Number:UZBRU_VHH2_1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001471-23
    A.3Full title of the trial
    Phase I/IIa study to evaluate the safety, biodistribution, radiation dosimetry and tumor imaging potential of 68GaNOTA-Anti-MMR-VHH2, a new radiopharmaceutical for in vivo imaging of Tumour-Associated Macrophages by means of Positron Emission Tomography (PET)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/IIa study to evaluate 68GaNOTA-anti-MMR-VHH2, a new tracer for positron emission tomografic imaging (PET/CT scan) of macrophages in tumor lesions.
    Studie ter evaluatie van 68GaNOTA-anti-MMR-VHH2, een nieuwe speurstof voor de analyse van MMR-positieve tumormacrofagen door middel van beeldvorming (PET/CT scan), en vergelijking met histologie van het letsel.
    Evaluation du 68GaNOTA-anti-MMR-VHH2, un nouveau traceur pour l’analyse des macrophages tumorales MMR-positives par tomographie d’émetteur de positon (PET/CT scan), et comparaison avec l’histologie au niveau de la lésion.
    A.4.1Sponsor's protocol code numberUZBRU_VHH2_1
    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 SponsorUZ Brussel
    B.1.3.4CountryBelgium
    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 supportUZ Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Brussel
    B.5.2Functional name of contact pointMarleen Keyaerts
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityJette
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number003224775020
    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 name68GaNOTA-Anti-MMR-VHH2
    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.3.8INN - Proposed INNGALLIUM (68GA) CHLORIDE
    D.3.9.3Other descriptive nameGALLIUM (68GA) CHLORIDE
    D.3.9.4EV Substance CodeSUB170788
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanti-MMR-VHH2
    D.3.9.2Current sponsor codeanti-MMR-VHH2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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 Yes
    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
    Tumour associated macrophages found in tumour lesions of different cancer types: breast-, head- and neck cancer or melanoma
    E.1.1.1Medical condition in easily understood language
    breast-, head- and neck cancer or melanoma
    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
    Part I:
    To evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2
    Part II:
    1. To evaluate tumour uptake of 68GaNOTA-Anti-MMR-VHH2 in patients with breast cancer, head-and-neck cancer or melanoma.
    2. To correlate uptake of 68GaNOTA-Anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection of the same lesion.
    E.2.2Secondary objectives of the trial
    Part I:
    To evaluate tumour uptake of 68GaNOTA-Anti-MMR-VHH2 in patients with breast cancer, head-and-neck cancer or melanoma and compare to immunohistological MMR staining after resection of a lesion
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part I
    Patients will only be included in the study if they meet all of the following criteria:
    - Patients who have given informed consent
    - Patients at least 18 years old
    - Patient with local, locally advanced or metastatic disease of breast cancer, head-and-neck cancer or melanoma, who is planned for resection or surgical biopsy of at least one lesion. In order to minimize partial volume effect the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.

    Part II
    Patients will only be included in the study if they meet all of the following criteria:
    - Patients who have given informed consent
    - Patients at least 18 years old
    - Patient with local, locally advanced or metastatic disease of breast cancer, head-and-neck cancer or melanoma, who is planned for resection or surgical biopsy of at least one lesion. In order to minimize partial volume effect the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions

    E.4Principal exclusion criteria
    Part I
    Patients will not be included in the study if one of the following criteria applies:
    - Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
    - Pregnant patients
    - Breast feeding patients
    - Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
    - Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
    - Patients with any serious active infection
    - Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
    - Patients who cannot communicate reliably with the investigator
    - Patients who are unlikely to cooperate with the requirements of the study
    - Patients who are unwilling and/or unable to give informed consent
    - Patients at increased risk of death from a pre-existing concurrent illness
    - Patients who participated already in this study

    Part II
    Patients will not be included in the study if one of the following criteria applies:
    - Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
    - Pregnant patients
    - Breast feeding patients
    - Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
    - Patients with any serious active infection
    - Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
    - Patients who cannot communicate reliably with the investigator
    - Patients who are unlikely to cooperate with the requirements of the study
    - Patients who are unwilling and/or unable to give informed consent
    - Patients at increased risk of death from a pre-existing concurrent illness
    - Patients who participated already in this study
    E.5 End points
    E.5.1Primary end point(s)
    Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2 via clinical and laboratory assessments.
    Human biodistribution and dosimetry via blood sampling for blood curves, via PET imaging for organ uptake and dosimetry.
    Tumour targeting potential via uptake values on PET imaging, and correlation to immunohistological MMR staining
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2, human biodistribution and dosimetry after completion of part I (6 study patients)
    Tumour targeting potential and correlation to immunohistological MMR staining: after completion of part II (total of 31 study patients)
    E.5.2Secondary end point(s)
    not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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) 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) 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-12-17. Yes
    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 state31
    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
    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 Decision2019-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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