Cancer Malignancies known to overexpress GRPR
Conditions
Interventions
Each study subject will receive a single dose (5.5mL) of study product by IV
injection on visit "Day 1"
Sponsors
Advanced Accelerator Applications International S.A.
Eligibility
Age
18 Years to 99 Years
Inclusion 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 tumour, for whom a less than 6-month-old biopsy 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 tumour type, CT, MRI) within 3 months prior to the administration of [68Ga]-NeoBOMB1. • 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
Exclusion criteria: • Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) 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 68Gallium, 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 |
|---|---|
| Primary Study Endpoint •*Number and location of tumour lesions detected by [68Ga]-NeoBOMB1 overall and for each tumour type •*Calculation of the ratio tumour/background SUV and calculation of percentage absorbed dose in tumour overall and for each tumour type. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Study Endpoints •*Standard safety parameters (clinical monitoring, laboratory, ECG) •*Tolerability and safety of the administration of a diagnostic dose of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR as determined by absence of: - increased number of SAEs compared to other peptide-based radiotracers; - clinically relevant changes of physiological parameters (blood pressure, heart rate, ECG findings) •*Generation of decay corrected tissue TACs from [68Ga]-NeoBOMB1 PET/CT images in normal organs, tumour lesions. •*Quantification of urinary excretion of [68Ga]-NeoBOMB1 •*Calculation of half-life of [68Ga]-NeoBOMB1 in blood •*Generation of non-decay-corrected TACs from [68Ga]-NeoBOMB1 PET/CT images in normal organs, tumour lesions •*Calculation of residence times in organs and tumour lesions of [68Ga]-NeoBOMB1 •*Calculation of absorbed doses and effective whole body dose of [68Ga]-NeoBOMB1 •*Calculation of the SUV of each lesion •*Number and location of tumour lesion detected by [68Ga]-NeoBOMB1 in comparison with comparable standard imaging modalities such as FDG-PET •*Calculation of the [68Ga]-NeoBOMB1 PET overall, positive and negative on a lesion-by-lesion basis as well as on a patient basis relative to the standard imaging overall and for each tumour type •*Comparison of number of patients with tumour lesions detected and number of tumour lesions detected by [68Ga]-NeoBOMB1 with cytology and/or histopathology from archival and/or recent biopsy specimens •*Calculation of the [68Ga]-NeoBOMB1 PET sensitivity and specificity on a lesion-bylesion basis for all lesions with associated biopsy data, and on a patient basis relative to histopathology / cytology data Exploratory Study Endpoints •*Absorbed tumour doses of [177Lu]-NeoBOMB1 extrapolated from 68Ga-dosimetric data and definition of dose limiting organ for radionuclide therapy | — |
Countries
Netherlands
Outcome results
None listed