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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARTBIO Inc.

Criteria

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.