TheranosticTrials.org

Clinical Trial · NCT03724253

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

Overview

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).

Sponsor

Advanced Accelerator Applications

Phase

Phase 2

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03724253

Drug / Compound

NeoBOMB1

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Subjects with histologically-confirmed tumor for whom a recent biopsy (not older than 6-months old) has been performed.
  • The Eastern Cooperative Oncology (ECOG) performance status 0-2.
  • 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
  • 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.
  • 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

Exclusion

  • any condition that precludes raised arms position
  • prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide
  • hematological toxicity grade \> 2 (Toxicity Grading Scale in vaccine clinical trials)
  • history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
  • subjects with positive pregnancy test (urine dipstick), and/or currently breast-feeding
  • renal insufficiency or an eGFR \<50 ml/min/1.73m2
  • concurrent bladder outflow obstruction or unmanageable urinary incontinence
  • known or expected hypersensitivity to \[68Ga\]-NeoBOMB1 or any excipient present in \[68Ga\]-NeoBOMB1
  • 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
  • participation in any other investigational trial within 30 days of study entry