Clinical trial NCT03724253: [68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Prostate Cancer
Colorectal Cancer
Non Small Cell Lung Cancer
Small Cell Lung Cancer
Keywords: [68Ga]-NeoBOMB1
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Number of Lesions Detected by [68Ga]-NeoBOMB1
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
measure: Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
measure: Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
measure: Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
measure: Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
measure: Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
Secondary outcomes:
measure: Treatment Emergent Adverse Events Profile
timeFrame: From first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
measure: Number of Lesions Detected by Conventional Imaging
timeFrame: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Number of Participants With Lesions Detected by Conventional Imaging Per Location
timeFrame: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
timeFrame: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
timeFrame: Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
timeFrame: Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Absorbed Dose in Target Organs
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Effective Whole-body Dose
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Half-life of [68Ga]-NeoBOMB1 in Blood (T^1/2)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Observed Maximum Plasma Concentration (Cmax)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Area Under the Plasma Concentration-time Curve From the Time 0 to the Last Observed Quantifiable Concentration (AUC(0-t))
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: AUC(0-t) Divided by the Dose Administered (AUC(0-t)/D)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Total Systemic Clearance for Intravenous Administration (CL)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
measure: Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)
timeFrame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck Department of Nuclear Medicine
city: La Tronche
country: France
facility: University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire
city: Pessac
country: France
facility: University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: