NCT03724253 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2020-10-23

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Lesions Detected by [68Ga]-NeoBOMB1

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outcome · POSTED

Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location

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outcome · POSTED

Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location

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outcome · POSTED

Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors

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outcome · POSTED

Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs

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outcome · POSTED

Treatment Emergent Adverse Events Profile

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outcome · POSTED

Number of Lesions Detected by Conventional Imaging

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outcome · POSTED

Number of Participants With Lesions Detected by Conventional Imaging Per Location

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outcome · POSTED

Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging

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outcome · POSTED

Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging

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outcome · POSTED

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

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outcome · POSTED

Dosimetry Group: Absorbed Dose in Target Organs

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outcome · POSTED

Dosimetry Group: Effective Whole-body Dose

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outcome · POSTED

Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)

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outcome · POSTED

Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)

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outcome · POSTED

Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)

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outcome · POSTED

Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))

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outcome · POSTED

Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)

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outcome · POSTED

Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)

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outcome · POSTED

Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
intervention Names
Drug: [68Ga]-NeoBOMB1
label
Phase II dosimetry group
type
EXPERIMENTAL
description
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
intervention Names
Drug: [68Ga]-NeoBOMB1
label
Phase II non-dosimetry group
type
EXPERIMENTAL

interventions

arm Group Labels
Phase II dosimetry group
Phase II non-dosimetry group
description
\[68Ga\]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
name
[68Ga]-NeoBOMB1
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

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.

masking Info

masking: NONE

primary Purpose

DIAGNOSTIC

Enrollment

count: 19
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
measure
Number of Lesions Detected by [68Ga]-NeoBOMB1
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
measure
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
measure
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
description
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
measure
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
description
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
measure
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
description
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
measure
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
description
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
measure
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
description
For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.
measure
Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

secondary Outcomes

description
Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Grade 3/4/5 TEAEs, Serious Adverse Event TEAEs, Interruption of \[68Ga\]-NeoBOMB1 Due to Any TEAEs and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
measure
Treatment Emergent Adverse Events Profile
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.
description
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
measure
Number of Lesions Detected by Conventional Imaging
time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. The location of lesions identified by aforementioned PET imaging were to be compared with the location of lesions identified by the comparable conventional imaging. Only descriptive analysis performed.
measure
Number of Participants With Lesions Detected by Conventional Imaging Per Location
time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
At lesion level, overall, positive, and negative agreement of \[68Ga\]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows: * Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg * Positive agreement = 100% x Double positive / (Double positive + Comparator single positive) * Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).
measure
Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by \[68Ga\]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by \[68Ga\]-NeoBOMB1.
measure
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
time Frame
Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
The diagnostic performance of \[68Ga\]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens. Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on \[68Ga\]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on \[68Ga\]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).
measure
Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
time Frame
Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
The absorbed dose in target organs and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.
measure
Dosimetry Group: Absorbed Dose in Target Organs
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
The effective radiation dose was to be summarized with descriptive statistics.
measure
Dosimetry Group: Effective Whole-body Dose
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. The half-lives of distribution (T\^1/2 alpha) and elimination phases (T\^1/2 beta) were to be listed and summarized using descriptive statistics.
measure
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Tmax was to be listed and summarized using descriptive statistics.
measure
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Cmax was to be listed and summarized using descriptive statistics.
measure
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. AUC(0-t) was to be listed and summarized using descriptive statistics.
measure
Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Full study description

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

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice