Breast CancerPhase 2NeoFINDNCT03724253
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
A Phase 2 study testing [68Ga]-NeoBOMB1 in people with Breast Cancer and Prostate Cancer, run by Advanced Accelerator Applications at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- [68Ga]-NeoBOMB1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 Jul 2018to 5 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire
La Tronche
University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan
Pessac
Austria1 site
Medical University Innsbruck Department of Nuclear Medicine
Innsbruck
About this study
Official title: Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
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).
Read the 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).
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Being tested
- [68Ga]-NeoBOMB1
- Keywords
- [68Ga]-NeoBOMB1
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]-NeoBOMB1Drug
[68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
| Study group | Role | What they receive |
|---|---|---|
| Phase II dosimetry group | Experimental | 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)]. Receives: Drug: [68Ga]-NeoBOMB1 |
| Phase II non-dosimetry group | Experimental | 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)]. Receives: Drug: [68Ga]-NeoBOMB1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Secondary outcomes (16)
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.
Measured: 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.
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.
Measured: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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).
Measured: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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).
Measured: Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Effective Whole-body Dose
The effective radiation dose was to be summarized with descriptive statistics.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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.
Measured: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start3 Jul 2018
- Primary completion20 Jun 2019
- Study completion5 Jul 2019
Why it stopped: Recruitment was stopped before the target sample size was achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724253
- Sponsor's protocol ID
- A005D-E01-201
- Other IDs
- 2017-003432-37, CAAA503A12201, 2017
- Acronym
- NeoFIND
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2018
- Last updated
- 23 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
- ClinicalTrials.gov ID
- NCT03724253
- Acronym / sponsor ID
- NeoFIND / A005D-E01-201
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Keywords
- [68Ga]-NeoBOMB1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped before the target sample size was achieved.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 23 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase II dosimetry group | Experimental | Drug: [68Ga]-NeoBOMB1All 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)]. |
| Phase II non-dosimetry group | Experimental | Drug: [68Ga]-NeoBOMB1All 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)]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]-NeoBOMB1[68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors | Drug | Phase II dosimetry group, Phase II non-dosimetry group |
Primary outcome
Number of Lesions Detected by [68Ga]-NeoBOMB1
Time frame: [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
Time frame: [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
Time frame: [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
Time frame: [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
Time frame: [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
Time frame: [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
Time frame: [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
Time frame: [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.
16 secondary outcomes
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.
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
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
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
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
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
Dosimetry Group: Absorbed Dose in Target Organs
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Effective Whole-body Dose
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
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
Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [68Ga]-NeoBOMB1 in people with Breast Cancer and Prostate Cancer, run by Advanced Accelerator Applications at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lesions Detected by [68Ga]-NeoBOMB1 (time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.