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

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).

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).

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