Trial Outcomes & Findings for [68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) (NCT NCT03724253)

NCT ID: NCT03724253

Last Updated: 2020-10-23

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Results posted on

2020-10-23

Participant Flow

This study was conducted at 3 centers in 2 countries: Austria (1) and France (2).

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).

Participant milestones

Participant milestones
Measure	Breast All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Overall Study STARTED	5	5	5	3	1
Overall Study COMPLETED	5	5	5	3	1
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Total n=19 Participants Total of all reporting groups
Age, Continuous	61.8 Years STANDARD_DEVIATION 7.60 • n=5 Participants	65.4 Years STANDARD_DEVIATION 6.31 • n=7 Participants	64.2 Years STANDARD_DEVIATION 13.68 • n=5 Participants	64.7 Years STANDARD_DEVIATION 3.21 • n=4 Participants	54.0 Years STANDARD_DEVIATION NA • n=21 Participants	63.4 Years STANDARD_DEVIATION 8.46 • n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=8 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants
Race/Ethnicity, Customized Not Collected	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	11 Participants n=8 Participants
Baseline Weight	70.6 kilogram (kg) STANDARD_DEVIATION 10.53 • n=5 Participants	85.2 kilogram (kg) STANDARD_DEVIATION 7.46 • n=7 Participants	72.6 kilogram (kg) STANDARD_DEVIATION 8.63 • n=5 Participants	72.1 kilogram (kg) STANDARD_DEVIATION 23.38 • n=4 Participants	62.8 kilogram (kg) STANDARD_DEVIATION NA • n=21 Participants	74.8 kilogram (kg) STANDARD_DEVIATION 12.64 • n=8 Participants
Baseline Height	165.6 centimeter (cm) STANDARD_DEVIATION 3.21 • n=5 Participants	175.4 centimeter (cm) STANDARD_DEVIATION 5.94 • n=7 Participants	170.4 centimeter (cm) STANDARD_DEVIATION 6.23 • n=5 Participants	165.7 centimeter (cm) STANDARD_DEVIATION 3.51 • n=4 Participants	168.0 centimeter (cm) STANDARD_DEVIATION NA • n=21 Participants	169.6 centimeter (cm) STANDARD_DEVIATION 10.7 • n=8 Participants
Baseline Body Mass Index	25.84 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 4.563 • n=5 Participants	27.79 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 3.202 • n=7 Participants	24.90 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 1.514 • n=5 Participants	26.04 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 7.552 • n=4 Participants	22.25 kilogram per square metre (kg/m^2) STANDARD_DEVIATION NA • n=21 Participants	25.95 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 3.970 • n=8 Participants
Diagnostic Stage IIIA	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Diagnostic Stage IIIC	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Diagnostic Stage IV	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	16 Participants n=8 Participants
Time from Initial Diagnosis of Primary Disease	117.3 Months STANDARD_DEVIATION 64.61 • n=5 Participants	50.5 Months STANDARD_DEVIATION 74.48 • n=7 Participants	24.3 Months STANDARD_DEVIATION 25.40 • n=5 Participants	1.6 Months STANDARD_DEVIATION 1.46 • n=4 Participants	1.1 Months STANDARD_DEVIATION NA • n=21 Participants	50.9 Months STANDARD_DEVIATION 65.32 • n=8 Participants

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). 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.

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants 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 Lesions Detected by [68Ga]-NeoBOMB1	17.0 Lesion Standard Deviation 15.57	2.2 Lesion Standard Deviation 1.64	6.0 Lesion Standard Deviation 4.58	3.3 Lesion Standard Deviation 2.31	1.0 Lesion Standard Deviation NA Only one participant analyzed

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants 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 Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location Overall	5 Participants	5 Participants	3 Participants	3 Participants	1 Participants
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location Nodal	2 Participants	1 Participants	2 Participants	3 Participants	0 Participants
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location Skeletal	4 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location Skin/Superficial	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location Soft Tissue/Visceral	4 Participants	4 Participants	2 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

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.

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall (0.05 hours)	—	1.634 Standard Uptake Value (SUV) Standard Deviation 0.8221	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal (0.05 hours)	—	0.630 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal (0.05 hours)	—	1.890 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral (0.05 hours)	—	1.558 Standard Uptake Value (SUV) Standard Deviation 0.9517	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall (1.50 hours)	6.833 Standard Uptake Value (SUV) Standard Deviation 5.0645	11.638 Standard Uptake Value (SUV) Standard Deviation 15.9172	2.582 Standard Uptake Value (SUV) Standard Deviation 0.8142	1.560 Standard Uptake Value (SUV) Standard Deviation 0.4468	1.250 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal (1.50 hours)	4.720 Standard Uptake Value (SUV) Standard Deviation 5.4447	1.080 Standard Uptake Value (SUV) Standard Deviation 0.2263	1.700 Standard Uptake Value (SUV) Standard Deviation 0.3960	1.560 Standard Uptake Value (SUV) Standard Deviation 0.4468	1.250 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal (1.50 hours)	3.670 Standard Uptake Value (SUV) Standard Deviation 4.0164	1.470 Standard Uptake Value (SUV) Standard Deviation 0.7778	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skin/Superficial (1.50 hours)	4.370 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	0.560 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral (1.50 hours)	6.833 Standard Uptake Value (SUV) Standard Deviation 5.0645	14.043 Standard Uptake Value (SUV) Standard Deviation 17.2993	2.582 Standard Uptake Value (SUV) Standard Deviation 0.8142	1.427 Standard Uptake Value (SUV) Standard Deviation 0.4274	1.150 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall (2.50 hours)	6.903 Standard Uptake Value (SUV) Standard Deviation 5.4174	9.088 Standard Uptake Value (SUV) Standard Deviation 10.7319	2.258 Standard Uptake Value (SUV) Standard Deviation 0.9105	1.273 Standard Uptake Value (SUV) Standard Deviation 0.2386	0.850 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal (2.50 hours)	4.900 Standard Uptake Value (SUV) Standard Deviation 6.0528	0.800 Standard Uptake Value (SUV) Standard Deviation 0.2687	2.715 Standard Uptake Value (SUV) Standard Deviation 1.5344	1.273 Standard Uptake Value (SUV) Standard Deviation 0.2386	0.850 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal (2.50 hours)	3.685 Standard Uptake Value (SUV) Standard Deviation 4.4336	1.455 Standard Uptake Value (SUV) Standard Deviation 0.8415	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skin/Superficial (2.50 hours)	4.360 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	0.450 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral (2.50 hours)	6.903 Standard Uptake Value (SUV) Standard Deviation 5.4174	10.848 Standard Uptake Value (SUV) Standard Deviation 11.5294	2.060 Standard Uptake Value (SUV) Standard Deviation 0.5115	1.193 Standard Uptake Value (SUV) Standard Deviation 0.3250	0.710 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall (0.05 hours)	—	2.166 Standard Uptake Value (SUV) Standard Deviation 1.1164	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal (0.05 hours)	—	0.880 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal (0.05 hours)	—	2.480 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral (0.05 hours)	—	2.088 Standard Uptake Value (SUV) Standard Deviation 1.2731	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall (1.50 hours)	19.040 Standard Uptake Value (SUV) Standard Deviation 17.5106	17.326 Standard Uptake Value (SUV) Standard Deviation 24.2165	3.570 Standard Uptake Value (SUV) Standard Deviation 0.7504	2.097 Standard Uptake Value (SUV) Standard Deviation 0.6863	1.810 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal (1.50 hours)	9.070 Standard Uptake Value (SUV) Standard Deviation 11.3986	1.505 Standard Uptake Value (SUV) Standard Deviation 0.4313	2.090 Standard Uptake Value (SUV) Standard Deviation 0.5233	1.917 Standard Uptake Value (SUV) Standard Deviation 0.7139	1.450 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal (1.50 hours)	10.325 Standard Uptake Value (SUV) Standard Deviation 13.0461	2.135 Standard Uptake Value (SUV) Standard Deviation 0.9687	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skin/Superficial (1.50 hours)	7.400 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	0.750 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral (1.50 hours)	18.580 Standard Uptake Value (SUV) Standard Deviation 17.5086	20.953 Standard Uptake Value (SUV) Standard Deviation 26.3485	3.570 Standard Uptake Value (SUV) Standard Deviation 0.7504	2.097 Standard Uptake Value (SUV) Standard Deviation 0.6863	1.810 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall (2.50 hours)	23.120 Standard Uptake Value (SUV) Standard Deviation 19.7908	14.544 Standard Uptake Value (SUV) Standard Deviation 18.4921	2.890 Standard Uptake Value (SUV) Standard Deviation 0.5866	2.050 Standard Uptake Value (SUV) Standard Deviation 0.8314	1.390 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal (2.50 hours)	10.440 Standard Uptake Value (SUV) Standard Deviation 13.8169	1.305 Standard Uptake Value (SUV) Standard Deviation 0.3323	2.870 Standard Uptake Value (SUV) Standard Deviation 1.3859	1.783 Standard Uptake Value (SUV) Standard Deviation 0.6676	1.180 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal (2.50 hours)	15.475 Standard Uptake Value (SUV) Standard Deviation 20.9091	2.115 Standard Uptake Value (SUV) Standard Deviation 1.0677	—	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skin/Superficial (2.50 hours)	7.950 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	0.600 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral (2.50 hours)	22.140 Standard Uptake Value (SUV) Standard Deviation 19.3278	17.463 Standard Uptake Value (SUV) Standard Deviation 19.9790	2.890 Standard Uptake Value (SUV) Standard Deviation 0.5866	2.000 Standard Uptake Value (SUV) Standard Deviation 0.8982	1.390 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. 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.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall (0.15 hours)	5.615 Standard Uptake Value (SUV) Standard Deviation 5.1265	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal (0.15 hours)	2.565 Standard Uptake Value (SUV) Standard Deviation 1.0394	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal (0.15 hours)	2.140 Standard Uptake Value (SUV) Standard Deviation 0.2121	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skin/Superficial (0.15 hours)	1.250 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral (0.15 hours)	9.240 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall (1.00 hours)	4.840 Standard Uptake Value (SUV) Standard Deviation 5.1336	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal (1.00 hours)	2.035 Standard Uptake Value (SUV) Standard Deviation 1.1667	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal (1.00 hours)	1.935 Standard Uptake Value (SUV) Standard Deviation 1.2233	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skin/Superficial (1.00 hours)	1.520 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral (1.00 hours)	8.470 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall ( 2.00 hours)	4.935 Standard Uptake Value (SUV) Standard Deviation 5.4659	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal ( 2.00 hours)	1.865 Standard Uptake Value (SUV) Standard Deviation 1.1667	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal ( 2.00 hours)	1.635 Standard Uptake Value (SUV) Standard Deviation 0.7990	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skin/Superficial ( 2.00 hours)	1.650 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral ( 2.00 hours)	8.800 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Overall ( 4.00 hours)	5.105 Standard Uptake Value (SUV) Standard Deviation 5.7064	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Nodal ( 4.00 hours)	1.475 Standard Uptake Value (SUV) Standard Deviation 1.0819	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skeletal ( 4.00 hours)	1.930 Standard Uptake Value (SUV) Standard Deviation 1.2162	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Skin/Superficial ( 4.00 hours)	1.100 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location SUV mean:Soft Tissue/Visceral ( 4.00 hours)	9.140 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall( 0.15 hours)	7.575 Standard Uptake Value (SUV) Standard Deviation 6.7104	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal (0.15 hours)	3.405 Standard Uptake Value (SUV) Standard Deviation 0.8132	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal (0.15 hours)	2.740 Standard Uptake Value (SUV) Standard Deviation 0.3111	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skin/Superficial (0.15 hours)	1.450 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral (0.15 hours)	12.320 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall (1.00 hours)	11.550 Standard Uptake Value (SUV) Standard Deviation 13.7603	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal (1.00 hours)	2.660 Standard Uptake Value (SUV) Standard Deviation 1.1879	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal (1.00 hours)	2.595 Standard Uptake Value (SUV) Standard Deviation 1.5203	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skin/Superficial (1.00 hours)	1.750 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral (1.00 hours)	21.280 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall ( 2.00 hours)	13.680 Standard Uptake Value (SUV) Standard Deviation 17.1827	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal ( 2.00 hours)	2.625 Standard Uptake Value (SUV) Standard Deviation 1.5486	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal ( 2.00 hours)	2.445 Standard Uptake Value (SUV) Standard Deviation 1.3081	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skin/Superficial ( 2.00 hours)	2.080 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral ( 2.00 hours)	25.830 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Overall ( 4.00 hours)	13.950 Standard Uptake Value (SUV) Standard Deviation 17.5787	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Nodal ( 4.00 hours)	2.050 Standard Uptake Value (SUV) Standard Deviation 1.3011	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skeletal ( 4.00 hours)	3.205 Standard Uptake Value (SUV) Standard Deviation 2.3829	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Skin/Superficial ( 4.00 hours)	1.640 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location SUV max:Soft Tissue/Visceral ( 4.00 hours)	26.380 Standard Uptake Value (SUV) Standard Deviation NA Only one participant analyzed	—	—	—	—

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 15 min post-dose (T1 Chest)	0.00347 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 15 min post-dose (T2 Left rib)	0.00384 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 15 min post-dose (T3 Spine)	0.00469 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 1 hour post-dose (T1 Chest)	0.00218 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 1 hour post-dose (T2 Left rib)	0.00251 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 1 hour post-dose (T3 Spine)	0.00225 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 2 hours post-dose (T1 Chest)	0.00149 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 2 hours post-dose (T2 Left rib)	0.00173 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 2 hours post-dose (T3 Spine)	0.00185 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 4 hours post-dose (T1 Chest)	0.00129 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 4 hours post-dose (T2 Left rib)	0.00167 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 1: 4 hours post-dose (T3 Spine)	0.00195 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T1 lungL)	0.00367 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T2 lungR)	0.00466 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T3 liverL)	0.01353 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T4 liverR1)	0.01304 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T5 liverR2)	0.01504 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T6 sacrumL)	0.00315 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T7 liverP)	0.01218 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 15 min post-dose (T8 liverR)	0.01079 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T1 lungL)	0.00455 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T2 lungR)	0.00463 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T3 liverL)	0.01800 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T4 liverR1)	0.01400 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T5 liverR2)	0.01928 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T6 sacrumL)	0.00289 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T7 liverP)	0.01180 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 1 hour post-dose (T8 liverR)	0.00961 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T1 lungL)	0.00481 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T2 lungR)	0.00377 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T3 liverL)	0.00984 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T4 liverR1)	0.01527 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T5 liverR2)	0.02197 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T6 sacrumL)	0.00254 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T7 liverP)	0.01242 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 2 hours post-dose (T8 liverR)	0.01088 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T1 lungL)	0.00385 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors articipant 2: 4 hours post-dose (T2 lungR)	0.00248 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T3 liverL)	0.01782 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T4 liverR1)	0.01164 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T5 liverR2)	0.02119 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T6 sacrumL)	0.00188 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T7 liverP)	0.01082 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors Participant 2: 4 hours post-dose (T8 liverR)	0.01012 %ID/g	—	—	—	—

PRIMARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Bladder)	0.03132 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Heart)	0.00600 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Kidney)	0.00688 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Liver)	0.00794 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Lung)	0.00218 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Marrow)	0.00331 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Pancreas)	0.04711 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 15 min post-dose (Spleen)	0.00409 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Bladder)	0.04259 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Heart)	0.00241 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Kidney)	0.00577 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Liver)	0.00296 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Lung)	0.00095 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Marrow)	0.00116 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Pancreas)	0.04836 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 1 hour post-dose (Spleen)	0.00211 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Bladder)	0.02141 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Heart)	0.00163 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Kidney)	0.00239 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Liver)	0.00197 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Lung)	0.00068 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Marrow)	0.00092 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Pancreas)	0.05445 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 2 hours post-dose (Spleen)	0.00141 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Bladder)	0.01790 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Heart)	0.00130 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Kidney)	0.00149 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Liver)	0.00162 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Lung)	0.00062 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Marrow)	0.00035 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Pancreas)	0.06280 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 1: 4 hours post-dose (Spleen)	0.00120 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Bladder)	0.02682 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Heart)	0.00340 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Kidney)	0.00480 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Liver)	0.00866 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Lung)	0.00124 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Marrow)	0.00186 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Pancreas)	0.02146 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 15 min post-dose (Spleen)	0.00338 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Bladder)	0.06480 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Heart)	0.00207 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Kidney)	0.00380 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Liver)	0.00564 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Lung)	0.00088 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Marrow)	0.00136 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Pancreas)	0.02909 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 1 hour post-dose (Spleen)	0.00256 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Bladder)	0.04055 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Heart)	0.00142 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Kidney)	0.00505 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Liver)	0.00428 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Lung)	0.00059 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Marrow)	0.00100 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Pancreas)	0.03450 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 2 hours post-dose (Spleen)	0.00191 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Bladder)	0.11045 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Heart)	0.00093 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Kidney)	0.00278 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Liver)	0.00317 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Lung)	0.00039 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Marrow)	0.00072 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Pancreas)	0.03745 %ID/g	—	—	—	—
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs Participant 2: 4 hours post-dose (Spleen)	0.00145 %ID/g	—	—	—	—

SECONDARY outcome

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.

Population: Full Analysis Set (FAS)

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.

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Treatment Emergent Adverse Events Profile Treatment-Emergent Adverse Events (TEAEs)	0 Participants	1 Participants	3 Participants	3 Participants	1 Participants
Treatment Emergent Adverse Events Profile IMP-Related TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Profile Grade 3/4/5 TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Treatment Emergent Adverse Events Profile IMP-Related Grade 3/4/5 TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Profile Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Treatment Emergent Adverse Events Profile IMP-Related Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Profile TEAEs Interruption of [68Ga]-NeoBOMB1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Profile IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Profile Deaths Due to AEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

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.

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants 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 Lesions Detected by Conventional Imaging	18.4 Lesion Standard Deviation 15.81	13.8 Lesion Standard Deviation 21.51	12.2 Lesion Standard Deviation 9.86	10.0 Lesion Standard Deviation 7.55	2.0 Lesion Standard Deviation NA Only one participant analyzed

SECONDARY outcome

Timeframe: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

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.

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants 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 Participants With Lesions Detected by Conventional Imaging Per Location Overall	5 Participants	5 Participants	5 Participants	3 Participants	1 Participants
Number of Participants With Lesions Detected by Conventional Imaging Per Location Nodal	4 Participants	1 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Lesions Detected by Conventional Imaging Per Location Skeletal	4 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Lesions Detected by Conventional Imaging Per Location Skin/Superficial	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Lesions Detected by Conventional Imaging Per Location Soft Tissue/Visceral	4 Participants	4 Participants	5 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS).

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).

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Overall (Positive Agreement)	52.2 Percent agreement Interval 41.5 to 62.7	14.5 Percent agreement Interval 7.2 to 25.0	29.5 Percent agreement Interval 18.5 to 42.6	33.3 Percent agreement Interval 17.3 to 52.8	50.0 Percent agreement Interval 1.3 to 98.7
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Overall (Overall Agreement)	37.2 Percent agreement Interval 28.9 to 46.2	14.3 Percent agreement Interval 7.1 to 24.7	29.5 Percent agreement Interval 18.5 to 42.6	33.3 Percent agreement Interval 17.3 to 52.8	50.0 Percent agreement Interval 1.3 to 98.7
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Nodal (Positive Agreement)	64.3 Percent agreement Interval 35.1 to 87.2	0.0 Percent agreement Interval 0.0 to 30.8	66.7 Percent agreement Interval 9.4 to 99.2	26.9 Percent agreement Interval 11.6 to 47.8	0.0 Percent agreement Interval 0.0 to 97.5
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Nodal (Overall agreement)	64.3 Percent agreement Interval 35.1 to 87.2	0.0 Percent agreement Interval 0.0 to 28.5	66.7 Percent agreement Interval 9.4 to 99.2	26.9 Percent agreement Interval 11.6 to 47.8	0.0 Percent agreement Interval 0.0 to 97.5
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skeletal (Positive Agreement)	22.9 Percent agreement Interval 12.0 to 37.3	11.1 Percent agreement Interval 4.2 to 22.6	—	—	—
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skeletal (Overall agreement)	18.3 Percent agreement Interval 9.5 to 30.4	11.1 Percent agreement Interval 4.2 to 22.6	—	—	—
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skin/Superficial (Positive Agreement)	100.0 Percent agreement Interval 15.8 to 100.0	—	0.0 Percent agreement Interval 0.0 to 97.5	—	—
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skin/Superficial (Overall agreement)	100.0 Percent agreement Interval 15.8 to 100.0	—	0.0 Percent agreement Interval 0.0 to 97.5	—	—
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Soft Tissue/Visceral (Positive Agreement)	92.9 Percent agreement Interval 76.5 to 99.1	80.0 Percent agreement Interval 28.4 to 99.5	28.1 Percent agreement Interval 17.0 to 41.5	75.0 Percent agreement Interval 19.4 to 99.4	100.0 Percent agreement Interval 2.5 to 100.0
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Soft Tissue/Visceral (Overall agreement)	49.1 Percent agreement Interval 35.1 to 63.2	80.0 Percent agreement Interval 28.4 to 99.5	28.1 Percent agreement Interval 17.0 to 41.5	75.0 Percent agreement Interval 19.4 to 99.4	100.0 Percent agreement Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS).

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.

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Soft Tissue/Visceral (Positive Agreement)	100.0 Percent agreement Interval 39.8 to 100.0	100.0 Percent agreement Interval 39.8 to 100.0	40.0 Percent agreement Interval 5.3 to 85.3	100.0 Percent agreement Interval 29.2 to 100.0	100.0 Percent agreement Interval 2.5 to 100.0
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Overall (Positive Agreement)	100.0 Percent agreement Interval 47.8 to 100.0	100.0 Percent agreement Interval 47.8 to 100.0	60.0 Percent agreement Interval 14.7 to 94.7	100.0 Percent agreement Interval 29.2 to 100.0	100.0 Percent agreement Interval 2.5 to 100.0
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Overall (Overall Agreement)	100.0 Percent agreement Interval 47.8 to 100.0	100.0 Percent agreement Interval 47.8 to 100.0	60.0 Percent agreement Interval 14.7 to 94.7	100.0 Percent agreement Interval 29.2 to 100.0	100.0 Percent agreement Interval 2.5 to 100.0
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Nodal (Positive Agreement)	50.0 Percent agreement Interval 6.8 to 93.2	0.0 Percent agreement Interval 0.0 to 97.5	100.0 Percent agreement Interval 15.8 to 100.0	100.0 Percent agreement Interval 29.2 to 100.0	0.0 Percent agreement Interval 0.0 to 97.5
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Nodal (Overall agreement)	50.0 Percent agreement Interval 6.8 to 93.2	0.0 Percent agreement Interval 0.0 to 84.2	100.0 Percent agreement Interval 15.8 to 100.0	100.0 Percent agreement Interval 29.2 to 100.0	0.0 Percent agreement Interval 0.0 to 97.5
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skeletal (Positive Agreement)	100.0 Percent agreement Interval 39.8 to 100.0	100.0 Percent agreement Interval 15.8 to 100.0	—	—	—
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skeletal (Overall agreement)	100.0 Percent agreement Interval 39.8 to 100.0	100.0 Percent agreement Interval 15.8 to 100.0	—	—	—
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skin/Superficial (Positive Agreement)	100.0 Percent agreement Interval 15.8 to 100.0	—	0.0 Percent agreement Interval 0.0 to 97.5	—	—
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Skin/Superficial (Overall agreement)	100.0 Percent agreement Interval 15.8 to 100.0	—	0.0 Percent agreement Interval 0.0 to 97.5	—	—
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging Soft Tissue/Visceral (Overall agreement)	100.0 Percent agreement Interval 39.8 to 100.0	100.0 Percent agreement Interval 39.8 to 100.0	40.0 Percent agreement Interval 5.3 to 85.3	100.0 Percent agreement Interval 29.2 to 100.0	100.0 Percent agreement Interval 2.5 to 100.0

SECONDARY outcome

Timeframe: Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

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 was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).

Outcome measures

Outcome measures
Measure	Breast n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence	80.0 Percent agreement Interval 28.4 to 99.5	100.0 Percent agreement Interval 47.8 to 100.0	20.0 Percent agreement Interval 0.5 to 71.6	100.0 Percent agreement Interval 29.2 to 100.0	0.0 Percent agreement Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

The absorbed dose in target organs and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Alveolar interstital (Lungs)	0.0359 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Bone Marrow	0.0118 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Heart	0.0361 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Kidneys	0.0467 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Liver	0.0670 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Pancreas	0.3620 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Spleen	0.0221 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 1-Urinary bladder wall	0.0683 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Alveolar interstital (Lungs)	0.0241 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Bone Marrow	0.0064 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Heart	0.0158 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Kidneys	0.0339 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Liver	0.0450 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Pancreas	0.2270 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Spleen	0.0189 mGy/MBq	—	—	—	—
Dosimetry Group: Absorbed Dose in Target Organs Participant 2-Urinary bladder wall	0.1010 mGy/MBq	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

The effective radiation dose was to be summarized with descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Effective Whole-body Dose Participant 1	0.0203 mSv/MBq	—	—	—	—
Dosimetry Group: Effective Whole-body Dose Participant 2	0.0151 mSv/MBq	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. The half-lives of distribution (T\^1/2 alpha) and elimination phases (T\^1/2 beta) were to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) Participant 1 - T^1/2 alpha	7.39 min	—	—	—	—
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) Participant 1 - T^1/2 beta	40.35 min	—	—	—	—
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) Participant 2- T^1/2 alpha	1.73 min	—	—	—	—
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) Participant 2- T^1/2 beta	32.61 min	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Tmax was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax) Participant 1	5.78 min	—	—	—	—
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax) Participant 2	5.73 min	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Cmax was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax) Participant 1	15.95 kBq/cc	—	—	—	—
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax) Participant 2	31.31 kBq/cc	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t) was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t)) Participant 1	40.67 MBq-s/cc	—	—	—	—
Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t)) Participant 2	44.85 MBq-s/cc	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t)/D was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D) Participant 1	0.2101 s/cc	—	—	—	—
Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D) Participant 2	0.2301 s/cc	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-inf) was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) Participant 1	44.49 MBq-s/cc	—	—	—	—
Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) Participant 2	70.21 MBq-s/cc	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. CL was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL) Participant 1	43.50 cc/s	—	—	—	—
Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL) Participant 2	2.78 cc/s	—	—	—	—

SECONDARY outcome

Timeframe: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. As the total volume of excreted urine was not recorded, no percentage of urinary excretion could be calculated.

Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Vd was to be listed and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Breast n=2 Participants All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)	NA L Standard Deviation NA NA: total volume of excreted urine was not recorded. Thus, no % of urinary excretion could be calculated.	—	—	—	—

Adverse Events

Breast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Prostate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Colorectal

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Non-Small Cell Lung Cancer (NSCLC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Small-Cell Lung Cancer (SCLC)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Breast n=5 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.

Other adverse events

Other adverse events
Measure	Breast n=5 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Prostate n=5 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Colorectal n=5 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Non-Small Cell Lung Cancer (NSCLC) n=3 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].	Small-Cell Lung Cancer (SCLC) n=1 participants at risk All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Blood and lymphatic system disorders Hyperfibrinogenaemia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Endocrine disorders Hyperparathyroidism	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Injury, poisoning and procedural complications Post procedural constipation	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Investigations Blood cholinesterase decreased	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Investigations Blood creatine phosphokinase increased	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Investigations Blood lactate dehydrogenase increased	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Investigations Blood urea decreased	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Investigations C-reactive protein increased	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Metabolism and nutrition disorders Hyperalbuminaemia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Nervous system disorders Paralysis recurrent laryngeal nerve	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Psychiatric disorders Insomnia	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Renal and urinary disorders Haematuria	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	33.3% 1/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	100.0% 1/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.
Vascular disorders Hypertension	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	20.0% 1/5 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/3 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.	0.00% 0/1 • Adverse events (AEs) were collected from informed consent signature through study completion (Day 14). 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.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER