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    Clinical Trial Results:
    A Phase I/IIa study to evaluate safety, biodistribution, dosimetry and preliminary diagnostic performance of 68Ga-NeoBOMB1 in patients with advanced TKI-treated GIST using positron-emission tomography/computer tomography (PET/CT).

    Summary
    EudraCT number
    		 2016-002053-38
    Trial protocol
    		 AT  
    Global end of trial date
    09 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2020
    First version publication date
    23 May 2020
    Other versions
    Summary report(s)
    		 Study Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    MITIGATE-NeoBOMB1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02931929
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Anichstraße 35, Innsbruck, Austria, 6020
    Public contact
    Department of nuclear medicine, Medical University Innsbruck, +43 51250422651, irene.virgolini@i-med.ac.at
    Scientific contact
    Department of nuclear medicine, Medical University Innsbruck, +43 51250422651, irene.virgolini@i-med.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I part: • Safety, tolerability • Human pharmacokinetics and dosimetry data to determine the organ doses and to identify potentially dose-limiting critical organs through PBPK modelling Phase I/IIa part: • Safety, tolerability • Preliminary targeting properties of 68Ga-NeoBOMB1 in advanced, GRP positive GIST tumours.
    Protection of trial subjects
    Patients received a PET-Scan with Tracerapplication, blood and urine samples were taken, 3 times ECG and pregnancy tests in WOCBP
    Background therapy
    		 Diagnostic CT + contrast agent, Low-dose whole-body CT
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    5
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Due to a very low incidence and prevalence as well as pre-determined imaging schedules in local patients with known GIST diagnosis, recruitment was very difficult throughout the study. Recruitment was supported by Mannheim Medical University, a specialized European centre for GIST which contributed 5 patients to the study.

    Pre-assignment
    Screening details
    		 All subjects have gastrointestinal stromal tumours, previously or currently under TKI treatment, including at least 50% TKI-resistant patients. The screening examinations must be performed between 1 and 28 days before being enrolled in the study. Overall, 9 participants were screened and enrolled in this study.

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Tracer Application NeoBOMB1
    Arm description
    		 68Ga-NeoBOMB1 imaging will be performed using 3D PET/CT Three-dimensional PET will be used to investigate 68Ga-NeoBOMB1 biodistribution in detail. PET/CT will be used to (a) demonstrate 68Ga-NeoBOMB1 binding inside or in proximity to the structural tumour lesion, as observed on CT (tumour targeting), and (b) to provide attenuation correction and partial volume correction data for the PET measurements. Image transfer and processing will be performed per Image.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kit for the preparation of 68Ga-NeoBOMB1
    Investigational medicinal product code
    436047
    Other name
    GalliaPharm
    Pharmaceutical forms
    Radionuclide generator
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients received a single injection of 68Ga-NeoBOMB1 at 3 MBq/ kg body weight (with a minimum of 150 and a maximum of 250 MBq)

    Number of subjects in period 1
    		Tracer Application NeoBOMB1
    Started
    9
    Completed
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall study
    Reporting group description
    		 All treated patients

    Reporting group values
    		 overall study Total
    Number of subjects
    		 9 9
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 4 4
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.4 ( 11.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Tracer Application NeoBOMB1
    Reporting group description
    		 68Ga-NeoBOMB1 imaging will be performed using 3D PET/CT Three-dimensional PET will be used to investigate 68Ga-NeoBOMB1 biodistribution in detail. PET/CT will be used to (a) demonstrate 68Ga-NeoBOMB1 binding inside or in proximity to the structural tumour lesion, as observed on CT (tumour targeting), and (b) to provide attenuation correction and partial volume correction data for the PET measurements. Image transfer and processing will be performed per Image.

    Primary: Human pharmakokinetics

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    End point title
    		 Human pharmakokinetics [1]
    End point description
    Generation of decay corrected time activity curves from 68Ga-NeoBOMB1 PET/CT images in normal organs, tumour lesions. Quantification of urinary excretion of 68Ga-NeoBOMB1 Calculation of half-life of 68Ga-NeoBOMB1 in blood
    End point type
    Primary
    End point timeframe
    Day 0
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been done due to small number of participants
    End point values
    		 Tracer Application NeoBOMB1
    Number of subjects analysed
    6
    Units: mSv/ MBq
    arithmetic mean (standard deviation)
        urinary excretion of 68Ga-NeoBOMB1
    26 ( 5 )
        half-life of 68Ga-NeoBOMB1 in blood
    41 ( 15 )
        half-life of 68Ga-NeoBOMB1 in serum
    35 ( 8 )
    No statistical analyses for this end point

    Primary: Safety & tolerability

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    End point title
    		 Safety & tolerability [2]
    End point description
    Tolerability and safety of the administration of 68Ga-NeoBOMB1 in a diagnostic dose Last follow-up visit (visit 3) for previous participant in first 3 participants
    End point type
    Primary
    End point timeframe
    Day 0- Day 8
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statisitcal analyses have been done due to small number of participants
    End point values
    		 Tracer Application NeoBOMB1
    Number of subjects analysed
    6
    Units: SAEs/ AES
    number (not applicable)
        Number of SAEs
    0
        Number of AEs
    6
    No statistical analyses for this end point

    Primary: Dosimetry

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    End point title
    		 Dosimetry [3]
    End point description
    Generation of non-decay-corrected time activity curves and residence times from 68Ga-NeoBOMB1 PET/CT images in normal organs, tumour lesions Calculation of absorbed doses and effective whole body dose of 68Ga-NeoBOMB1, also by PBPK modelling of 68Ga-NeoBOMB1
    End point type
    Primary
    End point timeframe
    Day 0- Day 5
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been done due to small number of participants
    End point values
    		 Tracer Application NeoBOMB1
    Number of subjects analysed
    6
    Units: mSv/ MBq
    arithmetic mean (standard deviation)
        effective whole body dose of 68Ga-NeoBOMB1
    0.0287 ( 0.0063 )
    No statistical analyses for this end point

    Primary: Preliminary targeting properties

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    End point title
    		 Preliminary targeting properties [4]
    End point description
    Description of 68Ga-NeoBOMB1 accumulation in tumour lesion (number of lesions, SUV value per lesion) and comparison with known tumour lesions. Comparison of tumour targeting with immunhistopathology (at least in Phase I/IIa patients)
    End point type
    Primary
    End point timeframe
    Day0- Day5
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been done due to small number of participants
    End point values
    		 Tracer Application NeoBOMB1
    Number of subjects analysed
    9
    Units: Ga-NeoBOMB1
    number (not applicable)
        Positive imaging finding for primary lesion
    2
        Positive imaging finding for liver metastases
    4
        Positive imaging finding for other metastases
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    28.11.2016-09.04.2019
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 9 (33.33%)
    Blood and lymphatic system disorders
    Neutophila
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Alterations of aPTT and PT
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    General disorders and administration site conditions
    Nightly sweats
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    2
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypophosphatemia
         subjects affected / exposed
    1 / 9 (11.11%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As we were limited by the EU FP7 project, we had to stop recriutment before we achieved including 12 patients into the study.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30775647
    http://www.ncbi.nlm.nih.gov/pubmed/29137110
    http://www.ncbi.nlm.nih.gov/pubmed/27754750
    http://www.ncbi.nlm.nih.gov/pubmed/27493272
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