[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
Condition: Breast Cancer; Prostate Cancer; Colorectal Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: [68Ga]-NeoBOMB1
Intervention description: [68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: [68Ga]-NeoBOMB1

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).
    

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