Breast Cancer, Colorectal Cancer, Non Small Cell Lung Cancer, Prostate Cancer, Small Cell Lung Cancer
Conditions
Keywords
[68Ga]-NeoBOMB1
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).
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).
Interventions
DRUG[68Ga]-NeoBOMB1
\[68Ga\]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
Sponsors
Advanced Accelerator Applications
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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). |
| 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. |
| 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. |
Countries
Austria, France
Participant flow
Recruitment details
This study was conducted at 3 centers in 2 countries: Austria (1) and France (2).
Pre-assignment details
A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).
Participants by arm
| Arm | Count |
|---|---|
| Breast All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\]. | 5 |
| Prostate All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\]. | 5 |
| Colorectal All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\]. | 5 |
| Non-Small Cell Lung Cancer (NSCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\]. | 3 |
| Small-Cell Lung Cancer (SCLC) All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\]. | 1 |
| Total | 19 |
Baseline characteristics
| Characteristic | Breast | Prostate | Colorectal | Non-Small Cell Lung Cancer (NSCLC) | Small-Cell Lung Cancer (SCLC) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 61.8 Years STANDARD_DEVIATION 7.6 | 65.4 Years STANDARD_DEVIATION 6.31 | 64.2 Years STANDARD_DEVIATION 13.68 | 64.7 Years STANDARD_DEVIATION 3.21 | 54.0 Years | 63.4 Years STANDARD_DEVIATION 8.46 |
| Baseline Body Mass Index | 25.84 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 4.563 | 27.79 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 3.202 | 24.90 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 1.514 | 26.04 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 7.552 | 22.25 kilogram per square metre (kg/m^2) | 25.95 kilogram per square metre (kg/m^2) STANDARD_DEVIATION 3.97 |
| Baseline Height | 165.6 centimeter (cm) STANDARD_DEVIATION 3.21 | 175.4 centimeter (cm) STANDARD_DEVIATION 5.94 | 170.4 centimeter (cm) STANDARD_DEVIATION 6.23 | 165.7 centimeter (cm) STANDARD_DEVIATION 3.51 | 168.0 centimeter (cm) | 169.6 centimeter (cm) STANDARD_DEVIATION 10.7 |
| Baseline Weight | 70.6 kilogram (kg) STANDARD_DEVIATION 10.53 | 85.2 kilogram (kg) STANDARD_DEVIATION 7.46 | 72.6 kilogram (kg) STANDARD_DEVIATION 8.63 | 72.1 kilogram (kg) STANDARD_DEVIATION 23.38 | 62.8 kilogram (kg) | 74.8 kilogram (kg) STANDARD_DEVIATION 12.64 |
| Diagnostic Stage IIIA | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Diagnostic Stage IIIC | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Diagnostic Stage IV | 5 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants | 16 Participants |
| Race/Ethnicity, Customized Not Collected | 5 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 5 Participants | 4 Participants | 2 Participants | 0 Participants | 11 Participants |
| Time from Initial Diagnosis of Primary Disease | 117.3 Months STANDARD_DEVIATION 64.61 | 50.5 Months STANDARD_DEVIATION 74.48 | 24.3 Months STANDARD_DEVIATION 25.4 | 1.6 Months STANDARD_DEVIATION 1.46 | 1.1 Months | 50.9 Months STANDARD_DEVIATION 65.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 5 | 1 / 5 | 3 / 5 | 3 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 3 | 1 / 1 |
Outcome results
Primary
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
Primary
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
Primary
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 0.799 |
| Breast | 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) | — |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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) | — |
Primary
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (2.50 hours) | 1.305 Standard Uptake Value (SUV) | Standard Deviation 0.3323 |
| Prostate | 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 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Skeletal (2.50 hours) | 2.115 Standard Uptake Value (SUV) | Standard Deviation 1.0677 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (1.50 hours) | 17.326 Standard Uptake Value (SUV) | Standard Deviation 24.2165 |
| Prostate | 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) | — |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (1.50 hours) | 1.505 Standard Uptake Value (SUV) | Standard Deviation 0.4313 |
| Prostate | 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) | — |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (2.50 hours) | 17.463 Standard Uptake Value (SUV) | Standard Deviation 19.979 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Skeletal (1.50 hours) | 2.135 Standard Uptake Value (SUV) | Standard Deviation 0.9687 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (1.50 hours) | 20.953 Standard Uptake Value (SUV) | Standard Deviation 26.3485 |
| Prostate | 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 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (2.50 hours) | 14.544 Standard Uptake Value (SUV) | Standard Deviation 18.4921 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Skin/Superficial (1.50 hours) | 0.750 Standard Uptake Value (SUV) | — |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (1.50 hours) | 2.090 Standard Uptake Value (SUV) | Standard Deviation 0.5233 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (2.50 hours) | 2.870 Standard Uptake Value (SUV) | Standard Deviation 1.3859 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (2.50 hours) | 2.890 Standard Uptake Value (SUV) | Standard Deviation 0.5866 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (2.50 hours) | 2.890 Standard Uptake Value (SUV) | Standard Deviation 0.5866 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Skin/Superficial (2.50 hours) | 0.600 Standard Uptake Value (SUV) | — |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (1.50 hours) | 3.570 Standard Uptake Value (SUV) | Standard Deviation 0.7504 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (1.50 hours) | 3.570 Standard Uptake Value (SUV) | Standard Deviation 0.7504 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (2.50 hours) | 1.783 Standard Uptake Value (SUV) | Standard Deviation 0.6676 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (1.50 hours) | 2.097 Standard Uptake Value (SUV) | Standard Deviation 0.6863 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (1.50 hours) | 1.917 Standard Uptake Value (SUV) | Standard Deviation 0.7139 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (1.50 hours) | 2.097 Standard Uptake Value (SUV) | Standard Deviation 0.6863 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (2.50 hours) | 2.050 Standard Uptake Value (SUV) | Standard Deviation 0.8314 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (2.50 hours) | 2.000 Standard Uptake Value (SUV) | Standard Deviation 0.8982 |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (2.50 hours) | 1.390 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (1.50 hours) | 1.810 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (1.50 hours) | 1.450 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Overall (1.50 hours) | 1.810 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Soft Tissue/Visceral (2.50 hours) | 1.390 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location | SUV max:Nodal (2.50 hours) | 1.180 Standard Uptake Value (SUV) | — |
Primary
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
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)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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) | — |
| Breast | 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 |
| Breast | 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 |
| Breast | 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 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (2.50 hours) | 0.800 Standard Uptake Value (SUV) | Standard Deviation 0.2687 |
| Prostate | 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 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Skeletal (2.50 hours) | 1.455 Standard Uptake Value (SUV) | Standard Deviation 0.8415 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (1.50 hours) | 11.638 Standard Uptake Value (SUV) | Standard Deviation 15.9172 |
| Prostate | 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) | — |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (1.50 hours) | 1.080 Standard Uptake Value (SUV) | Standard Deviation 0.2263 |
| Prostate | 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) | — |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (2.50 hours) | 10.848 Standard Uptake Value (SUV) | Standard Deviation 11.5294 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Skeletal (1.50 hours) | 1.470 Standard Uptake Value (SUV) | Standard Deviation 0.7778 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (1.50 hours) | 14.043 Standard Uptake Value (SUV) | Standard Deviation 17.2993 |
| Prostate | 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 |
| Prostate | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (2.50 hours) | 9.088 Standard Uptake Value (SUV) | Standard Deviation 10.7319 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Skin/Superficial (1.50 hours) | 0.560 Standard Uptake Value (SUV) | — |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (1.50 hours) | 1.700 Standard Uptake Value (SUV) | Standard Deviation 0.396 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (2.50 hours) | 2.715 Standard Uptake Value (SUV) | Standard Deviation 1.5344 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (2.50 hours) | 2.258 Standard Uptake Value (SUV) | Standard Deviation 0.9105 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (2.50 hours) | 2.060 Standard Uptake Value (SUV) | Standard Deviation 0.5115 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Skin/Superficial (2.50 hours) | 0.450 Standard Uptake Value (SUV) | — |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (1.50 hours) | 2.582 Standard Uptake Value (SUV) | Standard Deviation 0.8142 |
| Colorectal | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (1.50 hours) | 2.582 Standard Uptake Value (SUV) | Standard Deviation 0.8142 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (2.50 hours) | 1.273 Standard Uptake Value (SUV) | Standard Deviation 0.2386 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (1.50 hours) | 1.560 Standard Uptake Value (SUV) | Standard Deviation 0.4468 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (1.50 hours) | 1.560 Standard Uptake Value (SUV) | Standard Deviation 0.4468 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (1.50 hours) | 1.427 Standard Uptake Value (SUV) | Standard Deviation 0.4274 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (2.50 hours) | 1.273 Standard Uptake Value (SUV) | Standard Deviation 0.2386 |
| Non-Small Cell Lung Cancer (NSCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (2.50 hours) | 1.193 Standard Uptake Value (SUV) | Standard Deviation 0.325 |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (2.50 hours) | 0.850 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (1.50 hours) | 1.150 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (1.50 hours) | 1.250 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Overall (1.50 hours) | 1.250 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Soft Tissue/Visceral (2.50 hours) | 0.710 Standard Uptake Value (SUV) | — |
| Small-Cell Lung Cancer (SCLC) | Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location | SUV mean:Nodal (2.50 hours) | 0.850 Standard Uptake Value (SUV) | — |
Primary
Number of Lesions Detected by [68Ga]-NeoBOMB1
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast | Number of Lesions Detected by [68Ga]-NeoBOMB1 | 17.0 Lesion | Standard Deviation 15.57 |
| Prostate | Number of Lesions Detected by [68Ga]-NeoBOMB1 | 2.2 Lesion | Standard Deviation 1.64 |
| Colorectal | Number of Lesions Detected by [68Ga]-NeoBOMB1 | 6.0 Lesion | Standard Deviation 4.58 |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Lesions Detected by [68Ga]-NeoBOMB1 | 3.3 Lesion | Standard Deviation 2.31 |
| Small-Cell Lung Cancer (SCLC) | Number of Lesions Detected by [68Ga]-NeoBOMB1 | 1.0 Lesion | — |
Primary
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skin/Superficial | 2 Participants |
| Breast | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Overall | 5 Participants |
| Breast | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Soft Tissue/Visceral | 4 Participants |
| Breast | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Nodal | 2 Participants |
| Breast | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skeletal | 4 Participants |
| Prostate | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skin/Superficial | 0 Participants |
| Prostate | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skeletal | 2 Participants |
| Prostate | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Nodal | 1 Participants |
| Prostate | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Soft Tissue/Visceral | 4 Participants |
| Prostate | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Overall | 5 Participants |
| Colorectal | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skeletal | 0 Participants |
| Colorectal | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Overall | 3 Participants |
| Colorectal | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Nodal | 2 Participants |
| Colorectal | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skin/Superficial | 0 Participants |
| Colorectal | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Soft Tissue/Visceral | 2 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Soft Tissue/Visceral | 3 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Overall | 3 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skin/Superficial | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skeletal | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Nodal | 3 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skeletal | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Skin/Superficial | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Overall | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Soft Tissue/Visceral | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location | Nodal | 0 Participants |
Secondary
Dosimetry Group: Absorbed Dose in Target Organs
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Alveolar interstital (Lungs) | 0.0359 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Bone Marrow | 0.0118 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Heart | 0.0361 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Kidneys | 0.0467 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Liver | 0.0670 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Pancreas | 0.3620 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Spleen | 0.0221 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 1-Urinary bladder wall | 0.0683 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Alveolar interstital (Lungs) | 0.0241 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Bone Marrow | 0.0064 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Heart | 0.0158 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Kidneys | 0.0339 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Liver | 0.0450 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Pancreas | 0.2270 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Spleen | 0.0189 mGy/MBq |
| Breast | Dosimetry Group: Absorbed Dose in Target Organs | Participant 2-Urinary bladder wall | 0.1010 mGy/MBq |
Secondary
Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | 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 |
| Breast | 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
Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | 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 |
| Breast | 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
Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D) | Participant 1 | 0.2101 s/cc |
| Breast | Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D) | Participant 2 | 0.2301 s/cc |
Secondary
Dosimetry Group: Effective Whole-body Dose
The effective radiation dose was to be summarized with descriptive statistics.
Time frame: [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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: Effective Whole-body Dose | Participant 1 | 0.0203 mSv/MBq |
| Breast | Dosimetry Group: Effective Whole-body Dose | Participant 2 | 0.0151 mSv/MBq |
Secondary
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) | Participant 1 - T^1/2 alpha | 7.39 min |
| Breast | Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) | Participant 1 - T^1/2 beta | 40.35 min |
| Breast | Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) | Participant 2- T^1/2 alpha | 1.73 min |
| Breast | Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2) | Participant 2- T^1/2 beta | 32.61 min |
Secondary
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: Observed Maximum Plasma Concentration (Cmax) | Participant 1 | 15.95 kBq/cc |
| Breast | Dosimetry Group: Observed Maximum Plasma Concentration (Cmax) | Participant 2 | 31.31 kBq/cc |
Secondary
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax) | Participant 1 | 5.78 min |
| Breast | Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax) | Participant 2 | 5.73 min |
Secondary
Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL) | Participant 1 | 43.50 cc/s |
| Breast | Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL) | Participant 2 | 2.78 cc/s |
Secondary
Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)
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
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Breast | Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd) | NA L |
Secondary
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
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
Population: Full Analysis Set (FAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 64.3 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 92.9 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 37.2 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 64.3 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Overall agreement) | 100.0 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 52.2 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 49.1 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Positive Agreement) | 100.0 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Overall agreement) | 18.3 Percent agreement |
| Breast | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Positive Agreement) | 22.9 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 0.0 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 80.0 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 14.3 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 0.0 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 14.5 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Positive Agreement) | 11.1 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Overall agreement) | 11.1 Percent agreement |
| Prostate | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 80.0 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 66.7 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 28.1 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 29.5 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 28.1 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 29.5 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Positive Agreement) | 0.0 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Overall agreement) | 0.0 Percent agreement |
| Colorectal | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 66.7 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 75.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 75.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 33.3 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 26.9 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 33.3 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 26.9 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 100.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 50.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 50.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 0.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 0.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 100.0 Percent agreement |
Secondary
Number of Lesions Detected by Conventional Imaging
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast | Number of Lesions Detected by Conventional Imaging | 18.4 Lesion | Standard Deviation 15.81 |
| Prostate | Number of Lesions Detected by Conventional Imaging | 13.8 Lesion | Standard Deviation 21.51 |
| Colorectal | Number of Lesions Detected by Conventional Imaging | 12.2 Lesion | Standard Deviation 9.86 |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Lesions Detected by Conventional Imaging | 10.0 Lesion | Standard Deviation 7.55 |
| Small-Cell Lung Cancer (SCLC) | Number of Lesions Detected by Conventional Imaging | 2.0 Lesion | — |
Secondary
Number of Participants With Lesions Detected by Conventional Imaging Per Location
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skin/Superficial | 2 Participants |
| Breast | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Overall | 5 Participants |
| Breast | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Soft Tissue/Visceral | 4 Participants |
| Breast | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Nodal | 4 Participants |
| Breast | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skeletal | 4 Participants |
| Prostate | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skin/Superficial | 0 Participants |
| Prostate | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skeletal | 2 Participants |
| Prostate | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Nodal | 1 Participants |
| Prostate | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Soft Tissue/Visceral | 4 Participants |
| Prostate | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Overall | 5 Participants |
| Colorectal | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skeletal | 0 Participants |
| Colorectal | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Overall | 5 Participants |
| Colorectal | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Nodal | 2 Participants |
| Colorectal | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skin/Superficial | 1 Participants |
| Colorectal | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Soft Tissue/Visceral | 5 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Soft Tissue/Visceral | 3 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Overall | 3 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skin/Superficial | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skeletal | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Nodal | 3 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skeletal | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Skin/Superficial | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Overall | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Soft Tissue/Visceral | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Number of Participants With Lesions Detected by Conventional Imaging Per Location | Nodal | 1 Participants |
Secondary
Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast | Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence | 80.0 Percent agreement |
| Prostate | Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence | 100.0 Percent agreement |
| Colorectal | Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence | 20.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence | 100.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence | 0.0 Percent agreement |
Secondary
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
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
Population: Full Analysis Set (FAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 50.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 50.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Overall agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Positive Agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Overall agreement) | 100.0 Percent agreement |
| Breast | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Positive Agreement) | 100.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 0.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 100.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 100.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 0.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 100.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Positive Agreement) | 100.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skeletal (Overall agreement) | 100.0 Percent agreement |
| Prostate | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 100.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 100.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 40.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 60.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 40.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 60.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Positive Agreement) | 0.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Skin/Superficial (Overall agreement) | 0.0 Percent agreement |
| Colorectal | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 100.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 100.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 100.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 100.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 100.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 100.0 Percent agreement |
| Non-Small Cell Lung Cancer (NSCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 100.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Overall agreement) | 100.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Positive Agreement) | 100.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Overall (Overall Agreement) | 100.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Positive Agreement) | 0.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Nodal (Overall agreement) | 0.0 Percent agreement |
| Small-Cell Lung Cancer (SCLC) | Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging | Soft Tissue/Visceral (Positive Agreement) | 100.0 Percent agreement |
Secondary
Treatment Emergent Adverse Events Profile
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.
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Breast | Treatment Emergent Adverse Events Profile | Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | Deaths Due to AEs | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | Grade 3/4/5 TEAEs | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | Serious TEAEs | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | IMP-Related Serious TEAEs | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | IMP-Related Grade 3/4/5 TEAEs | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs | 0 Participants |
| Breast | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | IMP-Related Serious TEAEs | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | Deaths Due to AEs | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | Grade 3/4/5 TEAEs | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | IMP-Related Grade 3/4/5 TEAEs | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | Serious TEAEs | 0 Participants |
| Prostate | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | IMP-Related Grade 3/4/5 TEAEs | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | IMP-Related Serious TEAEs | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | Serious TEAEs | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | Grade 3/4/5 TEAEs | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Colorectal | Treatment Emergent Adverse Events Profile | Deaths Due to AEs | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | Grade 3/4/5 TEAEs | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | IMP-Related Grade 3/4/5 TEAEs | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | Serious TEAEs | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | IMP-Related Serious TEAEs | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Non-Small Cell Lung Cancer (NSCLC) | Treatment Emergent Adverse Events Profile | Deaths Due to AEs | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | Serious TEAEs | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | Grade 3/4/5 TEAEs | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | Deaths Due to AEs | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | IMP-Related TEAEs | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | IMP-Related Grade 3/4/5 TEAEs | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | TEAEs Interruption of [68Ga]-NeoBOMB1 | 0 Participants |
| Small-Cell Lung Cancer (SCLC) | Treatment Emergent Adverse Events Profile | IMP-Related Serious TEAEs | 0 Participants |