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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug | Experimental | 212Pb-NG001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 212Pb-NG001 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to 28 days |
| Body clearance | To study body clearance of 212Pb-NG001 by gamma camera imaging and by sample and probe measurements. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kjetil Berner, MD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
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| 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) | Up to 28 days |