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    Clinical Trial Results:
    Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor

    Summary
    EudraCT number
    		 2017-003432-37
    Trial protocol
    		 AT  
    Global end of trial date
    05 Jul 2019

    Results information
    Results version number
    		 v1
    This version publication date
    19 Jul 2020
    First version publication date
    19 Jul 2020
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    A005D-E01-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03724253
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 CAAA503A12201: Novartis
    Sponsors
    Sponsor organisation name
    Advanced Accelerator Applications SA
    Sponsor organisation address
    20, rue Diesel, Saint-Genis Pouilly, France, 01630
    Public contact
    Novartis Clinical Disclosure Office, Advanced Accelerator Applications SA, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Novartis Clinical Disclosure Office, Advanced Accelerator Applications SA, 41 613241111, Novartis.email@novartis.com
    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
    05 Jul 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective was to characterize preliminary targeting properties of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor (GRPR). Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jul 2018
    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: 8
    Country: Number of subjects enrolled
    France: 11
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    10
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 4 centers in 3 countries: Austria (1), France (2) and the Netherlands (1). The site in The Netherlands was activated, but did not recruit subjects.

    Pre-assignment
    Screening details
    		 A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Breast
    Arm description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]-NeoBOMB1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)]

    Arm title
    		 Prostate
    Arm description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]-NeoBOMB1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)]

    Arm title
    		 Colorectal
    Arm description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]-NeoBOMB1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)]

    Arm title
    		 Non-Small Cell Lung Cancer (NSCLC)
    Arm description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]-NeoBOMB1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)]

    Arm title
    		 Small-Cell Lung Cancer (SCLC)
    Arm description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
    Arm type
    		 Experimental

    Investigational medicinal product name
    [68Ga]-NeoBOMB1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Kit for radiopharmaceutical preparation
    Routes of administration
    Intravenous use
    Dosage and administration details
    All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)]

    Number of subjects in period 1
    		Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Started
    5
    5
    5
    3
    1
    Completed
    5
    5
    5
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Breast
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Prostate
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Colorectal
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC)
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Small-Cell Lung Cancer (SCLC)
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC) Total
    Number of subjects
    		 5 5 5 3 1 19
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 3 2 3 1 1 10
        From 65-84 years
    		 2 3 2 2 0 9
        85 years and over
    		 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 61.8 ( 7.60 ) 65.4 ( 6.31 ) 64.2 ( 13.68 ) 64.7 ( 3.21 ) 54.0 ( 999 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 5 0 1 1 1 8
        Male
    		 0 5 4 2 0 11
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 0 2 3 2 1 8
        Not Collected
    		 5 3 2 1 0 11
    Diagnostic Stage
    The overall diagnostic stage uses the stage at screening visit and the Tumour, Node, Metastasis (TNM) staging uses the latest available stage.
    Units: Subjects
        Stage IIIA
    		 0 1 0 1 0 2
        Stage IIIC
    		 0 0 0 1 0 1
        Stage IV
    		 5 4 5 1 1 16
    Baseline Weight
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    		 70.6 ( 10.53 ) 85.2 ( 7.46 ) 72.6 ( 8.63 ) 72.1 ( 23.38 ) 62.8 ( 999 ) -
    Baseline Height
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    		 165.6 ( 3.21 ) 175.4 ( 5.94 ) 170.4 ( 6.23 ) 165.7 ( 3.51 ) 168.0 ( 999 ) -
    Baseline Body Mass Index
    Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.
    Units: kilogram per square metre (kg/m^2)
        arithmetic mean (standard deviation)
    		 25.84 ( 4.563 ) 27.79 ( 3.202 ) 24.90 ( 1.514 ) 26.04 ( 7.552 ) 22.25 ( 999 ) -
    Time from Initial Diagnosis of Primary Disease
    Time from initial diagnosis (months) is calculated as (date of IMP administration - date of initial diagnosis + 1)/30.4375.
    Units: Months
        arithmetic mean (standard deviation)
    		 117.3 ( 64.61 ) 50.5 ( 74.48 ) 24.3 ( 25.40 ) 1.6 ( 1.46 ) 1.1 ( 999 ) -

    End points

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    End points reporting groups
    Reporting group title
    Breast
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Prostate
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Colorectal
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC)
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Reporting group title
    Small-Cell Lung Cancer (SCLC)
    Reporting group description
    		 All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].

    Primary: Number of lesions detected by [68Ga]-NeoBOMB1

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    End point title
    		 Number of lesions detected by [68Ga]-NeoBOMB1 [1]
    End point description
    The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    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: Only descriptive analysis performed. The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Lesion
        arithmetic mean (standard deviation)
    17.0 ( 15.57 )
    2.2 ( 1.64 )
    6.0 ( 4.58 )
    3.3 ( 2.31 )
    1.0 ( 999 )
    No statistical analyses for this end point

    Primary: Number of Participants with Lesions detected by [68Ga]-NeoBOMB1 per Location

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    End point title
    		 Number of Participants with Lesions detected by [68Ga]-NeoBOMB1 per Location [2]
    End point description
    The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    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: Only descriptive analysis performed. The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    3
    3
    1
    Units: No. of Participants with >= 1 lesion
        Overall
    5
    5
    3
    3
    1
        Nodal
    2
    1
    2
    3
    0
        Skeletal
    4
    2
    0
    0
    0
        Skin/Superficial
    2
    0
    0
    0
    0
        Soft Tissue/Visceral
    4
    4
    2
    3
    1
    No statistical analyses for this end point

    Primary: Non-Dosimetry Group: Standard Uptake Value (SUV) mean by timepoint and lesion location

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    End point title
    		 Non-Dosimetry Group: Standard Uptake Value (SUV) mean by timepoint and lesion location [3]
    End point description
    Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
    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: Only descriptive analysis performed. The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Participants with >= 1 SUVmean meas.
    arithmetic mean (standard deviation)
        SUV mean:Overall (0.05 hours)
    999 ( 999 )
    1.634 ( 0.8221 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Nodal (0.05 hours)
    999 ( 999 )
    0.630 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Skeletal (0.05 hours)
    999 ( 999 )
    1.890 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Skin/Superficial (0.05 hours)
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Soft Tissue/Visceral (0.05 hours)
    999 ( 999 )
    1.558 ( 0.9517 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Overall (1.50 hours)
    6.833 ( 5.0645 )
    11.638 ( 15.9172 )
    2.582 ( 0.8142 )
    1.560 ( 0.4468 )
    1.250 ( 999 )
        SUV mean:Nodal (1.50 hours)
    4.720 ( 5.4447 )
    1.080 ( 0.2263 )
    1.700 ( 0.3960 )
    1.560 ( 0.4468 )
    1.250 ( 999 )
        SUV mean:Skeletal (1.50 hours)
    3.670 ( 4.0164 )
    1.470 ( 0.7778 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Skin/Superficial (1.50 hours)
    4.370 ( 999 )
    999 ( 999 )
    0.560 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Soft Tissue/Visceral (1.50 hours)
    6.833 ( 5.0645 )
    14.043 ( 17.2993 )
    2.582 ( 0.8142 )
    1.427 ( 0.4274 )
    1.150 ( 999 )
        SUV mean:Overall (2.50 hours)
    6.903 ( 5.4174 )
    9.088 ( 10.7319 )
    2.258 ( 0.9105 )
    1.273 ( 0.2386 )
    0.850 ( 999 )
        SUV mean:Nodal (2.50 hours)
    4.900 ( 6.0528 )
    0.800 ( 0.2687 )
    2.715 ( 1.5344 )
    1.273 ( 0.2386 )
    0.850 ( 999 )
        SUV mean:Skeletal (2.50 hours)
    3.685 ( 4.4336 )
    1.455 ( 0.8415 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Skin/Superficial (2.50 hours)
    4.360 ( 999 )
    999 ( 999 )
    0.450 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV mean:Soft Tissue/Visceral (2.50 hours)
    6.903 ( 5.4174 )
    10.848 ( 11.5294 )
    2.060 ( 0.5115 )
    1.193 ( 0.3250 )
    0.710 ( 999 )
    No statistical analyses for this end point

    Primary: Non-Dosimetry Group: Standard Uptake Value (SUV) max by timepoint and lesion location

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    End point title
    		 Non-Dosimetry Group: Standard Uptake Value (SUV) max by timepoint and lesion location [4]
    End point description
    Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
    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: Only descriptive analysis performed. The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Participants with >= 1 SUVmax meas.
    arithmetic mean (standard deviation)
        SUV max:Overall (0.05 hours)
    999 ( 999 )
    2.166 ( 1.1164 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Nodal (0.05 hours)
    999 ( 999 )
    0.880 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Skeletal (0.05 hours)
    999 ( 999 )
    2.480 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Skin/Superficial (0.05 hours)
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Soft Tissue/Visceral (0.05 hours)
    999 ( 999 )
    2.088 ( 1.2731 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Overall (1.50 hours)
    19.040 ( 17.5106 )
    17.326 ( 24.2165 )
    3.570 ( 0.7504 )
    2.097 ( 0.6863 )
    1.810 ( 999 )
        SUV max:Nodal (1.50 hours)
    9.070 ( 11.3986 )
    1.505 ( 0.4313 )
    2.090 ( 0.5233 )
    1.917 ( 0.7139 )
    1.450 ( 999 )
        SUV max:Skeletal (1.50 hours)
    10.325 ( 13.0461 )
    2.135 ( 0.9687 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Skin/Superficial (1.50 hours)
    7.400 ( 999 )
    999 ( 999 )
    0.750 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Soft Tissue/Visceral (1.50 hours)
    18.580 ( 17.5086 )
    20.953 ( 26.3485 )
    3.570 ( 0.7504 )
    2.097 ( 0.6863 )
    1.810 ( 999 )
        SUV max:Overall (2.50 hours)
    23.120 ( 19.7908 )
    14.544 ( 18.4921 )
    2.890 ( 0.5866 )
    2.050 ( 0.8314 )
    1.390 ( 999 )
        SUV max:Nodal (2.50 hours)
    10.440 ( 13.8169 )
    1.305 ( 0.3323 )
    2.870 ( 1.3859 )
    1.783 ( 0.6676 )
    1.180 ( 999 )
        SUV max:Skeletal (2.50 hours)
    15.475 ( 20.9091 )
    2.115 ( 1.0677 )
    999 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Skin/Superficial (2.50 hours)
    7.950 ( 999 )
    999 ( 999 )
    0.600 ( 999 )
    999 ( 999 )
    999 ( 999 )
        SUV max:Soft Tissue/Visceral (2.50 hours)
    22.140 ( 19.3278 )
    17.463 ( 19.9790 )
    2.890 ( 0.5866 )
    2.000 ( 0.8982 )
    1.390 ( 999 )
    No statistical analyses for this end point

    Primary: Dosimetry Group: Standard Uptake Value (SUV) mean by timepoint and lesion location

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    End point title
    		 Dosimetry Group: Standard Uptake Value (SUV) mean by timepoint and lesion location [5] [6]
    End point description
    Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
    Notes
    [5] - 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: Only descriptive analysis performed. The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: Participants with >= 1 SUVmean meas.
    arithmetic mean (standard deviation)
        SUV mean:Overall (0.15 hours)
    5.615 ( 5.1265 )
        SUV mean:Nodal (0.15 hours)
    2.565 ( 1.0394 )
        SUV mean:Skeletal (0.15 hours)
    2.140 ( 0.2121 )
        SUV mean:Skin/Superficial (0.15 hours)
    1.250 ( 999 )
        SUV mean:Soft Tissue/Visceral (0.15 hours)
    9.240 ( 999 )
        SUV mean:Overall (1.00 hours)
    4.840 ( 5.1336 )
        SUV mean:Nodal (1.00 hours)
    2.035 ( 1.1667 )
        SUV mean:Skeletal (1.00 hours)
    1.935 ( 1.2233 )
        SUV mean:Skin/Superficial (1.00 hours)
    1.520 ( 999 )
        SUV mean:Soft Tissue/Visceral (1.00 hours)
    8.470 ( 999 )
        SUV mean:Overall ( 2.00 hours)
    4.935 ( 5.4659 )
        SUV mean:Nodal ( 2.00 hours)
    1.865 ( 1.1667 )
        SUV mean:Skeletal ( 2.00 hours)
    1.635 ( 0.7990 )
        SUV mean:Skin/Superficial ( 2.00 hours)
    1.650 ( 999 )
        SUV mean:Soft Tissue/Visceral ( 2.00 hours)
    8.800 ( 999 )
        SUV mean:Overall ( 4.00 hours)
    5.105 ( 5.7064 )
        SUV mean:Nodal ( 4.00 hours)
    1.475 ( 1.0819 )
        SUV mean:Skeletal ( 4.00 hours)
    1.930 ( 1.2162 )
        SUV mean:Skin/Superficial ( 4.00 hours)
    1.100 ( 999 )
        SUV mean:Soft Tissue/Visceral ( 4.00 hours)
    9.140 ( 999 )
    No statistical analyses for this end point

    Primary: Dosimetry Group: Standard Uptake Value (SUV) max by timepoint and lesion location

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    End point title
    		 Dosimetry Group: Standard Uptake Value (SUV) max by timepoint and lesion location [7] [8]
    End point description
    Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
    Notes
    [7] - 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: Only descriptive analysis performed. The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: Participants with >= 1 SUVmax meas.
    arithmetic mean (standard deviation)
        SUV max:Overall( 0.15 hours)
    7.575 ( 6.7104 )
        SUV max:Nodal (0.15 hours)
    3.405 ( 0.8132 )
        SUV max:Skeletal (0.15 hours)
    2.740 ( 0.3111 )
        SUV max:Skin/Superficial (0.15 hours)
    1.450 ( 999 )
        SUV max:Soft Tissue/Visceral (0.15 hours)
    12.320 ( 999 )
        SUV max:Overall (1.00 hours)
    11.550 ( 13.7603 )
        SUV max:Nodal (1.00 hours)
    2.660 ( 1.1879 )
        SUV max:Skeletal (1.00 hours)
    2.595 ( 1.5203 )
        SUV max:Skin/Superficial (1.00 hours)
    1.750 ( 999 )
        SUV max:Soft Tissue/Visceral (1.00 hours)
    21.280 ( 999 )
        SUV max:Overall ( 2.00 hours)
    13.680 ( 17.1827 )
        SUV max:Nodal ( 2.00 hours)
    2.625 ( 1.5486 )
        SUV max:Skeletal ( 2.00 hours)
    2.445 ( 1.3081 )
        SUV max:Skin/Superficial ( 2.00 hours)
    2.080 ( 999 )
        SUV max:Soft Tissue/Visceral ( 2.00 hours)
    25.830 ( 999 )
        SUV max:Overall ( 4.00 hours)
    13.950 ( 17.5787 )
        SUV max:Nodal ( 4.00 hours)
    2.050 ( 1.3011 )
        SUV max:Skeletal ( 4.00 hours)
    3.205 ( 2.3829 )
        SUV max:Skin/Superficial ( 4.00 hours)
    1.640 ( 999 )
        SUV max:Soft Tissue/Visceral ( 4.00 hours)
    26.380 ( 999 )
    No statistical analyses for this end point

    Primary: Dosimetry Group: Evaluation of percentage of injected dose reaching the target (TACs)

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    End point title
    		 Dosimetry Group: Evaluation of percentage of injected dose reaching the target (TACs) [9] [10]
    End point description
    For patients included in the dosimetry group, the percentage of injected dose reaching source organs and tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
    End point type
    Primary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
    Notes
    [9] - 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: Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: Injected dose
    999
    No statistical analyses for this end point

    Secondary: Treatment Emergent Adverse Events profile

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    End point title
    		 Treatment Emergent Adverse Events profile
    End point description
    Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of [68Ga]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
    End point type
    Secondary
    End point timeframe
    From first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Participants
        Treatment-Emergent Adverse Events (TEAEs)
    0
    1
    3
    3
    1
        IMP-Related TEAEs
    0
    0
    0
    0
    0
        Grade 3/4/5 TEAEs
    0
    0
    0
    0
    1
        IMP-Related Grade 3/4/5 TEAEs
    0
    0
    0
    0
    0
        Serious TEAEs
    0
    0
    0
    0
    1
        IMP-Related Serious TEAEs
    0
    0
    0
    0
    0
        TEAEs Interruption of [68Ga]-NeoBOMB1
    0
    0
    0
    0
    0
        IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1
    0
    0
    0
    0
    0
        Deaths Due to AEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of lesions detected by Conventional Imaging

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    End point title
    		 Number of lesions detected by Conventional Imaging
    End point description
    The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
    End point type
    Secondary
    End point timeframe
    Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Lesion
        arithmetic mean (standard deviation)
    18.4 ( 15.81 )
    13.8 ( 21.51 )
    12.2 ( 9.86 )
    10.0 ( 7.55 )
    2.0 ( 999 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Lesions detected by Conventional imaging per Location

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    End point title
    		 Number of Participants with Lesions detected by Conventional imaging per Location
    End point description
    The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. The location of lesions identified by aforementioned PET imaging were to be compared with the location of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
    End point type
    Secondary
    End point timeframe
    Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: No. of Participants with >= 1 lesion
        Overall
    5
    5
    5
    3
    1
        Nodal
    4
    1
    2
    3
    1
        Skeletal
    4
    2
    0
    0
    0
        Skin/Superficial
    2
    0
    1
    0
    0
        Soft Tissue/Visceral
    4
    4
    5
    3
    1
    No statistical analyses for this end point

    Secondary: Lesion-level analyses of diagnostics by [68Ga]-NeoBOMB1 compared with conventional imaging

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    End point title
    		 Lesion-level analyses of diagnostics by [68Ga]-NeoBOMB1 compared with conventional imaging
    End point description
    At lesion level, overall, positive, and negative agreement of [68Ga]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows: • Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg • Positive agreement = 100% x Double positive / (Double positive + Comparator single positive) • Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).
    End point type
    Secondary
    End point timeframe
    Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Agreement on Diagnostics
    number (confidence interval 95%)
        Overall (Positive Agreement)
    52.2 (41.5 to 62.7)
    14.5 (7.2 to 25.0)
    29.5 (18.5 to 42.6)
    33.3 (17.3 to 52.8)
    50.0 (1.3 to 98.7)
        Overall (Overall Agreement)
    37.2 (28.9 to 46.2)
    14.3 (7.1 to 24.7)
    29.5 (18.5 to 42.6)
    33.3 (17.3 to 52.8)
    50.0 (1.3 to 98.7)
        Nodal (Positive Agreement)
    64.3 (35.1 to 87.2)
    0.0 (0.0 to 30.8)
    66.7 (9.4 to 99.2)
    26.9 (11.6 to 47.8)
    0.0 (0.0 to 97.5)
        Nodal (Overall agreement)
    64.3 (35.1 to 87.2)
    0.0 (0.0 to 28.5)
    66.7 (9.4 to 99.2)
    26.9 (11.6 to 47.8)
    0.0 (0.0 to 97.5)
        Skeletal (Positive Agreement)
    22.9 (12.0 to 37.3)
    11.1 (4.2 to 22.6)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
        Skeletal (Overall agreement)
    18.3 (9.5 to 30.4)
    11.1 (4.2 to 22.6)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
        Skin/Superficial (Positive Agreement)
    100.0 (15.8 to 100.0)
    999 (999 to 999)
    0.0 (0.0 to 97.5)
    999 (999 to 999)
    999 (999 to 999)
        Skin/Superficial (Overall agreement)
    100.0 (15.8 to 100.0)
    999 (999 to 999)
    0.0 (0.0 to 97.5)
    999 (999 to 999)
    999 (999 to 999)
        Soft Tissue/Visceral (Positive Agreement)
    92.9 (76.5 to 99.1)
    80.0 (28.4 to 99.5)
    28.1 (17.0 to 41.5)
    75.0 (19.4 to 99.4)
    100.0 (2.5 to 100.0)
        Soft Tissue/Visceral (Overall agreement)
    49.1 (35.1 to 63.2)
    80.0 (28.4 to 99.5)
    28.1 (17.0 to 41.5)
    75.0 (19.4 to 99.4)
    100.0 (2.5 to 100.0)
    No statistical analyses for this end point

    Secondary: Patient-level analyses of diagnostics by [68Ga]-NeoBOMB1 compared with conventional imaging

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    End point title
    		 Patient-level analyses of diagnostics by [68Ga]-NeoBOMB1 compared with conventional imaging
    End point description
    At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1.
    End point type
    Secondary
    End point timeframe
    Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Agreement on Diagnostics
    number (confidence interval 95%)
        Overall (Positive Agreement)
    100.0 (47.8 to 100.0)
    100.0 (47.8 to 100.0)
    60.0 (14.7 to 94.7)
    100.0 (29.2 to 100.0)
    100.0 (2.5 to 100.0)
        Overall (Overall Agreement)
    100.0 (47.8 to 100.0)
    100.0 (47.8 to 100.0)
    60.0 (14.7 to 94.7)
    100.0 (29.2 to 100.0)
    100.0 (2.5 to 100.0)
        Nodal (Positive Agreement)
    50.0 (6.8 to 93.2)
    0.0 (0.0 to 97.5)
    100.0 (15.8 to 100.0)
    100.0 (29.2 to 100.0)
    0.0 (0.0 to 97.5)
        Nodal (Overall agreement)
    50.0 (6.8 to 93.2)
    0.0 (0.0 to 84.2)
    100.0 (15.8 to 100.0)
    100.0 (29.2 to 100.0)
    0.0 (0.0 to 97.5)
        Skeletal (Positive Agreement)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
        Skeletal (Overall agreement)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    999 (999 to 999)
    999 (999 to 999)
    999 (999 to 999)
        Skin/Superficial (Positive Agreement)
    100.0 (15.8 to 100.0)
    999 (999 to 999)
    0.0 (0.0 to 97.5)
    999 (999 to 999)
    999 (999 to 999)
        Skin/Superficial (Overall agreement)
    100.0 (15.8 to 100.0)
    999 (999 to 999)
    0.0 (0.0 to 97.5)
    999 (999 to 999)
    999 (999 to 999)
        Soft Tissue/Visceral (Positive Agreement)
    100.0 (39.8 to 100.0)
    100.0 (39.8 to 100.0)
    40.0 (5.3 to 85.3)
    100.0 (29.2 to 100.0)
    100.0 (2.5 to 100.0)
        Soft Tissue/Visceral (Overall agreement)
    100.0 (39.8 to 100.0)
    100.0 (39.8 to 100.0)
    40.0 (5.3 to 85.3)
    100.0 (29.2 to 100.0)
    100.0 (2.5 to 100.0)
    No statistical analyses for this end point

    Secondary: Organ-level analyses of Diagnostics by [68Ga]-NeoBOMB1 compared to histological evidence

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    End point title
    		 Organ-level analyses of Diagnostics by [68Ga]-NeoBOMB1 compared to histological evidence
    End point description
    The diagnostic performance of [68Ga]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens. Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on [68Ga]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on [68Ga]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity and specificity were to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative); Specificity = 100% x True negative / (True negative + False positive).
    End point type
    Secondary
    End point timeframe
    Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    End point values
    		 Breast Prostate Colorectal Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)
    Number of subjects analysed
    5
    5
    5
    3
    1
    Units: Agreement on Diagnostics
        number (confidence interval 95%)
    80.0 (28.4 to 99.5)
    100.0 (47.8 to 100.0)
    20.0 (0.5 to 71.6)
    100.0 (29.2 to 100.0)
    0.0 (0.0 to 97.5)
    No statistical analyses for this end point

    Secondary: Dosimetry Group: absorbed dose in tumor

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    End point title
    		 Dosimetry Group: absorbed dose in tumor [11]
    End point description
    The absorbed dose in tumor and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: mGy/MBq
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Effective whole-body dose

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    End point title
    		 Dosimetry Group: Effective whole-body dose [12]
    End point description
    The absorbed dose in tumor and the effective radiation dose were to be summarized with descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: μSv/MBq
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: half-life of [68Ga]-NeoBOMB1 in blood (T^1/2)

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    End point title
    		 Dosimetry Group: half-life of [68Ga]-NeoBOMB1 in blood (T^1/2) [13]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: min
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Time of maximum observed drug concentration occurrence (Tmax)

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    End point title
    		 Dosimetry Group: Time of maximum observed drug concentration occurrence (Tmax) [14]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: min
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Observed maximum plasma concentration (Cmax)

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    End point title
    		 Dosimetry Group: Observed maximum plasma concentration (Cmax) [15]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: kBq/cc
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t))

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    End point title
    		 Dosimetry Group: Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) [16]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: MBq-s/cc
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: AUC(0-t) divided by the dose administered (AUC(0-t)/D)

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    End point title
    		 Dosimetry Group: AUC(0-t) divided by the dose administered (AUC(0-t)/D) [17]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: s/cc
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf)

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    End point title
    		 Dosimetry Group: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) [18]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: MBq-s/cc
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Total systemic clearance for intravenous administration (CL)

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    End point title
    		 Dosimetry Group: Total systemic clearance for intravenous administration (CL) [19]
    End point description
    Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters (Cmax, tmax, AUC(0-t), AUC(0-t)/D, t1/2, AUC(0-inf), CL) were to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: cc/s
    999
    No statistical analyses for this end point

    Secondary: Dosimetry Group: Urinary excretion of [68Ga]-NeoBOMB1 (Vd)

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    End point title
    		 Dosimetry Group: Urinary excretion of [68Ga]-NeoBOMB1 (Vd) [20]
    End point description
    Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. PK parameters Vd was to be listed and summarized using descriptive statistics.
    End point type
    Secondary
    End point timeframe
    [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Dosimetry analysis only apply to subset of Breast Cancer patients
    End point values
    		 Breast
    Number of subjects analysed
    2
    Units: Liter (L)
        arithmetic mean (standard deviation)
    999 ( 999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events are collected and reported from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV).
    Adverse event reporting additional description
    Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 19 (5.26%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 19 (42.11%)
    Investigations
    Blood cholinesterase decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood urea decreased
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Post procedural constipation
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Procedural pain
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hypertension
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Nervous system disorders
    Paralysis recurrent laryngeal nerve
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hyperfibrinogenaemia
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    2 / 19 (10.53%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypochloraemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1
    Hyperalbuminaemia
         subjects affected / exposed
    1 / 19 (5.26%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2017
    Amendment 1: Remove reference to a specific commercially available generator for IP reconstitution
    14 Feb 2018
    Amendment 2: 1) Update with available information on IP related to safety and dosimetry, 2) Revision of the schedule of assessments, 3) Clarifications on patients assignments in dosimetry or non-dosimetry group, 4) Clarification of the optional status of the routine clinical follow-up, 5) Clarification about allowed concomitant medication, 6) Update on references to ICH E6 and declaration of Helsinki.
    05 Jul 2018
    Amendment 3: Deletion of the reference to patients presenting relapsed or refractory metastatic cancer for both dosimetry and non-dosimetry groups to allow inclusion of patients at any stage of the disease.
    06 Aug 2018
    Amendment 4 (country specific to France): Reference to patients presenting metastatic cancer, relapsed or refractory, added for dosimetry group

    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.
    Recruitment was stopped before the target sample size was achieved..
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