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

• Status: Terminated
• Trial end date: 2019-07-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advanced Accelerator Applications
• Treatments: Bombesin; Gastrin-Releasing Peptide; Gastrins

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