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

• Sponsor: Advanced Accelerator Applications (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03724253
• Collaborator: (none)
• Enrollment: 19
• Locations: 3
• Arms: 2
• Actual Duration (Months): 12.1
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Prostate Cancer; Colorectal Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer	Drug: [68Ga]-NeoBOMB1	Phase 2

Detailed Description

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study design included a dosimetry and non-dosimetry groups and with the following tumor types: Breast Cancer: dosimetry and non-dosimetry groups Prostate Cancer: dosimetry and non-dosimetry groups Colorectal cancer: non-dosimetry group Non-Small Cell Lung Cancer (NSCLC): non-dosimetry group Small-Cell Lung Cancer (SCLC): non-dosimetry group All data presentations were to be presented primarily by the overall population but were also to be repeated split by tumor type where relevant. Some presentations were also to be repeated split by whether or not the patient was found to have tumors bearing GRPR expression according to cytology and/or histopathology findings.The study design included a dosimetry and non-dosimetry groups and with the following tumor types:Breast Cancer: dosimetry and non-dosimetry groups Prostate Cancer: dosimetry and non-dosimetry groups Colorectal cancer: non-dosimetry group Non-Small Cell Lung Cancer (NSCLC): non-dosimetry group Small-Cell Lung Cancer (SCLC): non-dosimetry group All data presentations were to be presented primarily by the overall population but were also to be repeated split by tumor type where relevant. Some presentations were also to be repeated split by whether or not the patient was found to have tumors bearing GRPR expression according to cytology and/or histopathology findings.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
• Actual Study Start Date: Jul 3, 2018
• Actual Primary Completion Date: Jun 20, 2019
• Actual Study Completion Date: Jul 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase II dosimetry group 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)].	Drug: [68Ga]-NeoBOMB1; [68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
Experimental: Phase II non-dosimetry group 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)].	Drug: [68Ga]-NeoBOMB1; [68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors

Outcome Measures

Primary Outcome Measures

1. Number of Lesions Detected by [68Ga]-NeoBOMB1 [[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. Only descriptive analysis performed.

2. Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location [[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. Only descriptive analysis performed.

3. Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location [[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.

4. Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location [[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.

5. Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 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.

6. Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 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.

7. Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)]

   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.

8. Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)]

   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.

Secondary Outcome Measures

1. Treatment Emergent Adverse Events Profile [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.]

   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.

2. Number of Lesions Detected by Conventional Imaging [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.

3. Number of Participants With Lesions Detected by Conventional Imaging Per Location [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.

4. Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging [Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

   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).

5. Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging [Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

   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.

6. Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence [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).

7. Dosimetry Group: Absorbed Dose in Target Organs [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

   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.

8. Dosimetry Group: Effective Whole-body Dose [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

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

9. Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

   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.

10. Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

    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.

11. Dosimetry Group: Observed Maximum Plasma Concentration (Cmax) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

    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.

12. Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t)) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

    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.

13. Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

    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.

14. Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

    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.

15. Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

    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.

16. Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd) [[68Ga]-NeoBOMB1 PET imaging acquired at Day 1]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must be at least 18 years of age

• Subjects must have signed and dated an informed consent prior to any study-specific procedures

• Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.

• Dosimetry group: luminal breast cancer, adenocarcinoma of the prostate

• Non-dosimetry group: luminal breast cancer, adenocarcinoma of the prostate, small cell lung cancer, non-small cell lung cancer, colorectal carcinoma

• At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumor type, CT, MRI) within 3 months prior to [68Ga]-NeoBOMB1 administration

• The Eastern Cooperative Oncology (ECOG) performance status 0-2.

• Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.

Exclusion Criteria:

• renal insufficiency or an eGFR <50 ml/min/1.73m2

• hematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)

• participation in any other investigational trial within 30 days of study entry

• subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding

• concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results

• concurrent bladder outflow obstruction or unmanageable urinary incontinence

• known or expected hypersensitivity to [68Ga]-NeoBOMB1 or any excipient present in [68Ga]-NeoBOMB1

• any condition that precludes raised arms position

• prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide

• history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Innsbruck Department of Nuclear Medicine	Innsbruck		Austria
2	University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire	La Tronche		France
3	University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan	Pessac		France

Sponsors and Collaborators

• Advanced Accelerator Applications

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

• Statistical Analysis Plan - Jun 11, 2019
• Study Protocol - Jul 5, 2018

More Information

Publications

None provided.

• Responsible Party: Advanced Accelerator Applications
• ClinicalTrials.gov Identifier: NCT03724253
• Other Study ID Numbers: A005D-E01-201; 2017-003432-37; CAAA503A12201
• First Posted: Oct 30, 2018
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Advanced Accelerator Applications: [68Ga]-NeoBOMB1
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma

Study Results

Participant Flow

Recruitment Details	This study was conducted at 3 centers in 2 countries: Austria (1) and France (2).
Pre-assignment Detail	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).

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

Baseline Characteristics

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)	Total
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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 of all reporting groups
Overall Participants	5	5	5	3	1	19
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.8 (7.60)	65.4 (6.31)	64.2 (13.68)	64.7 (3.21)	54.0 (NA)	63.4 (8.46)
Sex: Female, Male (Count of Participants)
Female	5 100%	0 0%	1 20%	1 33.3%	1 100%	8 42.1%
Male	0 0%	5 100%	4 80%	2 66.7%	0 0%	11 57.9%
Race/Ethnicity, Customized (Number) [Number]
White	0 0%	2 40%	3 60%	2 66.7%	1 100%	8 42.1%
Not Collected	5 100%	3 60%	2 40%	1 33.3%	0 0%	11 57.9%
Baseline Weight (kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (kg)]	70.6 (10.53)	85.2 (7.46)	72.6 (8.63)	72.1 (23.38)	62.8 (NA)	74.8 (12.64)
Baseline Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]	165.6 (3.21)	175.4 (5.94)	170.4 (6.23)	165.7 (3.51)	168.0 (NA)	169.6 (10.7)
Baseline Body Mass Index (kilogram per square metre (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square metre (kg/m^2)]	25.84 (4.563)	27.79 (3.202)	24.90 (1.514)	26.04 (7.552)	22.25 (NA)	25.95 (3.970)
Diagnostic Stage (Count of Participants)
IIIA	0 0%	1 20%	0 0%	1 33.3%	0 0%	2 10.5%
IIIC	0 0%	0 0%	0 0%	1 33.3%	0 0%	1 5.3%
IV	5 100%	4 80%	5 100%	1 33.3%	1 100%	16 84.2%
Time from Initial Diagnosis of Primary Disease (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	117.3 (64.61)	50.5 (74.48)	24.3 (25.40)	1.6 (1.46)	1.1 (NA)	50.9 (65.32)

Outcome Measures

1. Primary Outcome

Title	Number of Lesions Detected by [68Ga]-NeoBOMB1
Description	The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

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

2. Primary Outcome

Title	Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
Description	The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	3	3	1
Overall	5 100%	5 100%	3 60%	3 100%	1 100%
Nodal	2 40%	1 20%	2 40%	3 100%	0 0%
Skeletal	4 80%	2 40%	0 0%	0 0%	0 0%
Skin/Superficial	2 40%	0 0%	0 0%	0 0%	0 0%
Soft Tissue/Visceral	4 80%	4 80%	2 40%	3 100%	1 100%

3. Primary Outcome

Title	Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
Description	Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

Outcome Measure Data

Analysis Population Description

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.

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

4. Primary Outcome

Title	Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
Description	Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

Outcome Measure Data

Analysis Population Description

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.

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

5. Primary Outcome

Title	Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
Description	Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
SUV mean:Overall (0.15 hours)	5.615 (5.1265)
SUV mean:Nodal (0.15 hours)	2.565 (1.0394)
SUV mean:Skeletal (0.15 hours)	2.140 (0.2121)
SUV mean:Skin/Superficial (0.15 hours)	1.250 (NA)
SUV mean:Soft Tissue/Visceral (0.15 hours)	9.240 (NA)
SUV mean:Overall (1.00 hours)	4.840 (5.1336)
SUV mean:Nodal (1.00 hours)	2.035 (1.1667)
SUV mean:Skeletal (1.00 hours)	1.935 (1.2233)
SUV mean:Skin/Superficial (1.00 hours)	1.520 (NA)
SUV mean:Soft Tissue/Visceral (1.00 hours)	8.470 (NA)
SUV mean:Overall ( 2.00 hours)	4.935 (5.4659)
SUV mean:Nodal ( 2.00 hours)	1.865 (1.1667)
SUV mean:Skeletal ( 2.00 hours)	1.635 (0.7990)
SUV mean:Skin/Superficial ( 2.00 hours)	1.650 (NA)
SUV mean:Soft Tissue/Visceral ( 2.00 hours)	8.800 (NA)
SUV mean:Overall ( 4.00 hours)	5.105 (5.7064)
SUV mean:Nodal ( 4.00 hours)	1.475 (1.0819)
SUV mean:Skeletal ( 4.00 hours)	1.930 (1.2162)
SUV mean:Skin/Superficial ( 4.00 hours)	1.100 (NA)
SUV mean:Soft Tissue/Visceral ( 4.00 hours)	9.140 (NA)

6. Primary Outcome

Title	Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
Description	Targeting properties of [68Ga]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
SUV max:Overall( 0.15 hours)	7.575 (6.7104)
SUV max:Nodal (0.15 hours)	3.405 (0.8132)
SUV max:Skeletal (0.15 hours)	2.740 (0.3111)
SUV max:Skin/Superficial (0.15 hours)	1.450 (NA)
SUV max:Soft Tissue/Visceral (0.15 hours)	12.320 (NA)
SUV max:Overall (1.00 hours)	11.550 (13.7603)
SUV max:Nodal (1.00 hours)	2.660 (1.1879)
SUV max:Skeletal (1.00 hours)	2.595 (1.5203)
SUV max:Skin/Superficial (1.00 hours)	1.750 (NA)
SUV max:Soft Tissue/Visceral (1.00 hours)	21.280 (NA)
SUV max:Overall ( 2.00 hours)	13.680 (17.1827)
SUV max:Nodal ( 2.00 hours)	2.625 (1.5486)
SUV max:Skeletal ( 2.00 hours)	2.445 (1.3081)
SUV max:Skin/Superficial ( 2.00 hours)	2.080 (NA)
SUV max:Soft Tissue/Visceral ( 2.00 hours)	25.830 (NA)
SUV max:Overall ( 4.00 hours)	13.950 (17.5787)
SUV max:Nodal ( 4.00 hours)	2.050 (1.3011)
SUV max:Skeletal ( 4.00 hours)	3.205 (2.3829)
SUV max:Skin/Superficial ( 4.00 hours)	1.640 (NA)
SUV max:Soft Tissue/Visceral ( 4.00 hours)	26.380 (NA)

7. Primary Outcome

Title	Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1: 15 min post-dose (T1 Chest)	0.00347
Participant 1: 15 min post-dose (T2 Left rib)	0.00384
Participant 1: 15 min post-dose (T3 Spine)	0.00469
Participant 1: 1 hour post-dose (T1 Chest)	0.00218
Participant 1: 1 hour post-dose (T2 Left rib)	0.00251
Participant 1: 1 hour post-dose (T3 Spine)	0.00225
Participant 1: 2 hours post-dose (T1 Chest)	0.00149
Participant 1: 2 hours post-dose (T2 Left rib)	0.00173
Participant 1: 2 hours post-dose (T3 Spine)	0.00185
Participant 1: 4 hours post-dose (T1 Chest)	0.00129
Participant 1: 4 hours post-dose (T2 Left rib)	0.00167
Participant 1: 4 hours post-dose (T3 Spine)	0.00195
Participant 2: 15 min post-dose (T1 lungL)	0.00367
Participant 2: 15 min post-dose (T2 lungR)	0.00466
Participant 2: 15 min post-dose (T3 liverL)	0.01353
Participant 2: 15 min post-dose (T4 liverR1)	0.01304
Participant 2: 15 min post-dose (T5 liverR2)	0.01504
Participant 2: 15 min post-dose (T6 sacrumL)	0.00315
Participant 2: 15 min post-dose (T7 liverP)	0.01218
Participant 2: 15 min post-dose (T8 liverR)	0.01079
Participant 2: 1 hour post-dose (T1 lungL)	0.00455
Participant 2: 1 hour post-dose (T2 lungR)	0.00463
Participant 2: 1 hour post-dose (T3 liverL)	0.01800
Participant 2: 1 hour post-dose (T4 liverR1)	0.01400
Participant 2: 1 hour post-dose (T5 liverR2)	0.01928
Participant 2: 1 hour post-dose (T6 sacrumL)	0.00289
Participant 2: 1 hour post-dose (T7 liverP)	0.01180
Participant 2: 1 hour post-dose (T8 liverR)	0.00961
Participant 2: 2 hours post-dose (T1 lungL)	0.00481
Participant 2: 2 hours post-dose (T2 lungR)	0.00377
Participant 2: 2 hours post-dose (T3 liverL)	0.00984
Participant 2: 2 hours post-dose (T4 liverR1)	0.01527
Participant 2: 2 hours post-dose (T5 liverR2)	0.02197
Participant 2: 2 hours post-dose (T6 sacrumL)	0.00254
Participant 2: 2 hours post-dose (T7 liverP)	0.01242
Participant 2: 2 hours post-dose (T8 liverR)	0.01088
Participant 2: 4 hours post-dose (T1 lungL)	0.00385
articipant 2: 4 hours post-dose (T2 lungR)	0.00248
Participant 2: 4 hours post-dose (T3 liverL)	0.01782
Participant 2: 4 hours post-dose (T4 liverR1)	0.01164
Participant 2: 4 hours post-dose (T5 liverR2)	0.02119
Participant 2: 4 hours post-dose (T6 sacrumL)	0.00188
Participant 2: 4 hours post-dose (T7 liverP)	0.01082
Participant 2: 4 hours post-dose (T8 liverR)	0.01012

8. Primary Outcome

Title	Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Outcome Measure Data

Analysis Population Description

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.

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

9. Secondary Outcome

Title	Treatment Emergent Adverse Events Profile
Description	Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of [68Ga]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS)

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	5	3	1
Treatment-Emergent Adverse Events (TEAEs)	0 0%	1 20%	3 60%	3 100%	1 100%
IMP-Related TEAEs	0 0%	0 0%	0 0%	0 0%	0 0%
Grade 3/4/5 TEAEs	0 0%	0 0%	0 0%	0 0%	1 100%
IMP-Related Grade 3/4/5 TEAEs	0 0%	0 0%	0 0%	0 0%	0 0%
Serious TEAEs	0 0%	0 0%	0 0%	0 0%	1 100%
IMP-Related Serious TEAEs	0 0%	0 0%	0 0%	0 0%	0 0%
TEAEs Interruption of [68Ga]-NeoBOMB1	0 0%	0 0%	0 0%	0 0%	0 0%
IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1	0 0%	0 0%	0 0%	0 0%	0 0%
Deaths Due to AEs	0 0%	0 0%	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Number of Lesions Detected by Conventional Imaging
Description	The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
Time Frame	Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	5	3	1
Mean (Standard Deviation) [Lesion]	18.4 (15.81)	13.8 (21.51)	12.2 (9.86)	10.0 (7.55)	2.0 (NA)

11. Secondary Outcome

Title	Number of Participants With Lesions Detected by Conventional Imaging Per Location
Description	The preliminary targeting properties of [68Ga]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. The location of lesions identified by aforementioned PET imaging were to be compared with the location of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
Time Frame	Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	5	3	1
Overall	5 100%	5 100%	5 100%	3 100%	1 100%
Nodal	4 80%	1 20%	2 40%	3 100%	1 100%
Skeletal	4 80%	2 40%	0 0%	0 0%	0 0%
Skin/Superficial	2 40%	0 0%	1 20%	0 0%	0 0%
Soft Tissue/Visceral	4 80%	4 80%	5 100%	3 100%	1 100%

12. Secondary Outcome

Title	Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
Description	At lesion level, overall, positive, and negative agreement of [68Ga]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows: Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg Positive agreement = 100% x Double positive / (Double positive + Comparator single positive) Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).
Time Frame	Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS).

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	5	3	1
Overall (Positive Agreement)	52.2	14.5	29.5	33.3	50.0
Overall (Overall Agreement)	37.2	14.3	29.5	33.3	50.0
Nodal (Positive Agreement)	64.3	0.0	66.7	26.9	0.0
Nodal (Overall agreement)	64.3	0.0	66.7	26.9	0.0
Skeletal (Positive Agreement)	22.9	11.1
Skeletal (Overall agreement)	18.3	11.1
Skin/Superficial (Positive Agreement)	100.0	0.0
Skin/Superficial (Overall agreement)	100.0	0.0
Soft Tissue/Visceral (Positive Agreement)	92.9	80.0	28.1	75.0	100.0
Soft Tissue/Visceral (Overall agreement)	49.1	80.0	28.1	75.0	100.0

13. Secondary Outcome

Title	Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
Description	At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by [68Ga]-NeoBOMB1.
Time Frame	Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS).

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	5	3	1
Overall (Positive Agreement)	100.0	100.0	60.0	100.0	100.0
Overall (Overall Agreement)	100.0	100.0	60.0	100.0	100.0
Nodal (Positive Agreement)	50.0	0.0	100.0	100.0	0.0
Nodal (Overall agreement)	50.0	0.0	100.0	100.0	0.0
Skeletal (Positive Agreement)	100.0	100.0
Skeletal (Overall agreement)	100.0	100.0
Skin/Superficial (Positive Agreement)	100.0	0.0
Skin/Superficial (Overall agreement)	100.0	0.0
Soft Tissue/Visceral (Positive Agreement)	100.0	100.0	40.0	100.0	100.0
Soft Tissue/Visceral (Overall agreement)	100.0	100.0	40.0	100.0	100.0

14. Secondary Outcome

Title	Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
Description	The diagnostic performance of [68Ga]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens. Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on [68Ga]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on [68Ga]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).
Time Frame	Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast	Prostate	Colorectal	Non-Small Cell Lung Cancer (NSCLC)	Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].	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)].	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)].	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)].	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)].
Measure Participants	5	5	5	3	1
Number (95% Confidence Interval) [Percent agreement]	80.0	100.0	20.0	100.0	0.0

15. Secondary Outcome

Title	Dosimetry Group: Absorbed Dose in Target Organs
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1-Alveolar interstital (Lungs)	0.0359
Participant 1-Bone Marrow	0.0118
Participant 1-Heart	0.0361
Participant 1-Kidneys	0.0467
Participant 1-Liver	0.0670
Participant 1-Pancreas	0.3620
Participant 1-Spleen	0.0221
Participant 1-Urinary bladder wall	0.0683
Participant 2-Alveolar interstital (Lungs)	0.0241
Participant 2-Bone Marrow	0.0064
Participant 2-Heart	0.0158
Participant 2-Kidneys	0.0339
Participant 2-Liver	0.0450
Participant 2-Pancreas	0.2270
Participant 2-Spleen	0.0189
Participant 2-Urinary bladder wall	0.1010

16. Secondary Outcome

Title	Dosimetry Group: Effective Whole-body Dose
Description	The effective radiation dose was to be summarized with descriptive statistics.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	0.0203
Participant 2	0.0151

17. Secondary Outcome

Title	Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1 - T^1/2 alpha	7.39
Participant 1 - T^1/2 beta	40.35
Participant 2- T^1/2 alpha	1.73
Participant 2- T^1/2 beta	32.61

18. Secondary Outcome

Title	Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	5.78
Participant 2	5.73

19. Secondary Outcome

Title	Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	15.95
Participant 2	31.31

20. Secondary Outcome

Title	Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	40.67
Participant 2	44.85

21. Secondary Outcome

Title	Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	0.2101
Participant 2	0.2301

22. Secondary Outcome

Title	Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	44.49
Participant 2	70.21

23. Secondary Outcome

Title	Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)
Description	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.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Participant 1	43.50
Participant 2	2.78

24. Secondary Outcome

Title	Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)
Description	Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Vd was to be listed and summarized using descriptive statistics.
Time Frame	[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Breast
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].
Measure Participants	2
Mean (Standard Deviation) [L]	NA (NA)

Adverse Events

Time Frame	Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
Adverse Event Reporting Description	Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
Arm/Group Title	Breast		Prostate		Colorectal		Non-Small Cell Lung Cancer (NSCLC)		Small-Cell Lung Cancer (SCLC)
Arm/Group Description	All eligible participants were to receive recommended dose of [68Ga]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)].		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)].		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)].		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)].		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)].
All Cause Mortality
	Breast		Prostate		Colorectal		Non-Small Cell Lung Cancer (NSCLC)		Small-Cell Lung Cancer (SCLC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		0/1 (0%)
Serious Adverse Events
	Breast		Prostate		Colorectal		Non-Small Cell Lung Cancer (NSCLC)		Small-Cell Lung Cancer (SCLC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
Blood and lymphatic system disorders
Leukopenia	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
Metabolism and nutrition disorders
Hyponatraemia	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
Other (Not Including Serious) Adverse Events
	Breast		Prostate		Colorectal		Non-Small Cell Lung Cancer (NSCLC)		Small-Cell Lung Cancer (SCLC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		1/5 (20%)		3/5 (60%)		3/3 (100%)		1/1 (100%)
Blood and lymphatic system disorders
Anaemia	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
Hyperfibrinogenaemia	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		1/1 (100%)
Endocrine disorders
Hyperparathyroidism	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
Injury, poisoning and procedural complications
Post procedural constipation	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)		0/1 (0%)
Procedural pain	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)		0/1 (0%)
Investigations
Blood cholinesterase decreased	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		0/1 (0%)
Blood creatine phosphokinase increased	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		0/1 (0%)
Blood lactate dehydrogenase increased	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		0/1 (0%)
Blood urea decreased	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
C-reactive protein increased	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		1/1 (100%)
Gamma-glutamyltransferase increased	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)		1/1 (100%)
Metabolism and nutrition disorders
Hyperalbuminaemia	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/3 (0%)		0/1 (0%)
Hypochloraemia	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)		1/1 (100%)
Nervous system disorders
Paralysis recurrent laryngeal nerve	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		0/1 (0%)
Psychiatric disorders
Insomnia	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)		0/1 (0%)
Renal and urinary disorders
Haematuria	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)		1/1 (100%)
Vascular disorders
Deep vein thrombosis	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)		0/1 (0%)
Hypertension	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)		0/1 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.