NCT03724253

[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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Advanced Accelerator Applications · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

• Breast Cancer
• Prostate Cancer
• Colorectal Cancer
• Non Small Cell Lung Cancer
• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	[68Ga]-NeoBOMB1	\[68Ga\]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors

Timeline

• Start date: 2018-07-03
• Primary completion: 2019-06-20
• Completion: 2019-07-05
• First posted: 2018-10-30
• Last updated: 2020-10-23
• Results posted: 2020-10-23

Locations

3 sites across 2 countries: Austria, France

Regulatory

• FDA-regulated drug study