NCT03872778

[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake

A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerabiity, Whole-body Distribution, Radiation Dosimetry and Anti-tumor Activity of [177Lu]-NeoB Administered in Patients With Advanced Solid Tumors Known to Overexpress Gastrin-releasing Peptide Receptor (GRPR)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Advanced Accelerator Applications · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of \[177Lu\]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with \[68Ga\]-NeoB lesion uptake.

Detailed description

This study was designed to establish whether the ligand NeoB, a high affinity antagonist for GRPR, could be used in a theragnostic approach for selection and therapy of GRPRexpressing malignancies: radiolabeled with (1) Gallium 68 (68Ga) to identify lesions and with (2) Lutetium-177 (177Lu) for the treatment of these lesions.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	[177Lu]-NeoB	\[177Lu\]-NeoB: peptide receptor radionuclide therapy
DRUG	[68Ga]-NeoB	\[68Ga\]-NeoB radioactive diagnostic agent
DRUG	LCZ696	dose strength 49/51 mg, film-coated tablets for oral use

Timeline

• Start date: 2019-05-24
• Primary completion: 2025-01-07
• Completion: 2025-11-27
• First posted: 2019-03-13
• Last updated: 2026-01-28

Locations

11 sites across 6 countries: United States, Austria, France, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study