An Early Phase 1 interventional study of 212Pb-NG001 in Metastatic Castration-resistant Prostate Cancer, sponsored by ARTBIO Inc.. Completed at 1 site in Norway. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by ARTBIO Inc. · Early Phase 1, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 3 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →ARTBIO Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
212Pb-NG001
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.
Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
To qualitatively determine whether 212Pb-NG001 can be used to produce images of sufficient clarity and sensitivity by SPECT/CT to confirm 212Pb-NG001 uptake and biodistribution.
Time frame: Up to 28 days
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to 28 days
Body clearance
To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements.
Time frame: Up to 2 days
Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP
To explore any signals of therapeutic effects on the laboratory parameters: prostate specific antigen (PSA) and alkaline phosphatase (ALP)
Time frame: Up to 28 days
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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ARTBIO Inc.