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Clinical Trial · NCT05725070
Phase 0/1 Study of 212Pb-NG001 in mCRPC
Overview
The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.
Sponsor
ARTBIO, Inc.Phase
Early Phase 1
Contacts
Kjetil Berner, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT05725070Drug / Compound
NG001
Isotope(s):
LEAD-212
Radioisotope: Pb-212
Theranostic Role: Therapeutic Agent
T1/2 (Half-Life): 10.6 Hours
Decay Mode: ALPHA, BETA, GAMMA
Energy: Alpha 6 MeV (25%), 6 MeV (10%), 8.7 MeV (71%) Beta 1.5 MeV (18%), 1.8 MeV (20%), 2.2 MeV (53%) Gamma 583 keV (30%), 2.6 MeV (36%)
Range: 50-100 micrometers
Decay Daughters: Bi212, Tl208, Po212, Pb208
Status: Clinical Trials Only, 2024 FDA Breakthrough Therapy Designation for ALPHAMEDIX™ GEP-NET Tumors
Target(s):
- PSMA
Ligand Class: Peptides
Chelator: TCMC
Eligibility
Inclusion
- Histological, pathological, and/or cytological confirmation of prostate cancer
- Metastatic castration resistant prostate cancer
- Adequate hematopoietic, kidney and liver functionKey
- Life expectancy \>6 months
- Failure of conventional treatment or such treatment not available/accepted by patient
- PSMA avid mCRPC lesions confirmed by PSMA PET/CT
- ECOG performance status of 0 to 2
Exclusion
- Concomitant diseases not compatible for radioactive therapy
- Previous PSMA-targeted radioligand therapy
- Concurrent or other cancer diagnosis last two years, except for carcinoma in situ
- Concurrent serious (as determined by the Principal Investigator) medical conditionsNote: Other protocol defined Inclusion/Exclusion criteria apply.
Patient Education
Patient education not yet provided.
Publications
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