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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
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* Drug: 212Pb-NG001


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug<br>212Pb-NG001 | Drug: 212Pb-NG001<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |