NCT05725070

Phase 0/1 Study of 212Pb-NG001 in mCRPC

Phase 0/1 Theragnostic Study in Patients With Metastatic Castration Resistant Prostate Cancer in Need of Salvage Therapy, Selected by 18F-PSMA-PET Imaging and Treated by Alpha-therapeutic Radioligand 212Pb-NG001

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: ARTBIO Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.

Detailed description

This is a single site, open label, non-randomized, non-controlled intervention study with an initial microdosing run-in part (phase 0), followed by a conventional dose-escalation phase 1 part.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	212Pb-NG001	212Pb-NG001 is a targeted alpha-emitting radiopharmaceutical conjugated to a PSMA targeting peptide. Patients will receive an initial single 10 MBq dose IV to explore the imaging potential of 212Pb-NG001.

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-07-06
• Completion: 2023-07-06
• First posted: 2023-02-13
• Last updated: 2023-10-06

Locations

1 site across 1 country: Norway