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

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

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.

Key Inclusion Criteria:

• ECOG performance status of 0 to 2
• Life expectancy >6 months
• Histological, pathological, and/or cytological confirmation of prostate cancer
• Metastatic castration resistant prostate cancer
• Failure of conventional treatment or such treatment not available/accepted by patient
• PSMA avid mCRPC lesions confirmed by PSMA PET/CT
• Adequate hematopoietic, kidney and liver function

Key Exclusion Criteria:

• Concurrent or other cancer diagnosis last two years, except for carcinoma in situ
• Concomitant diseases not compatible for radioactive therapy
• Previous PSMA-targeted radioligand therapy
• Concurrent serious (as determined by the Principal Investigator) medical conditions

Note: Other protocol defined Inclusion/Exclusion criteria apply.