Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Neuroendocrine Tumors
Trial Parameters
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Brief Summary
This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria: 1. Adult (ages ≥18) PRRT-naïve subjects with NETs by local pathology. 2. Locally advanced/unresectable or metastatic NETs. 3. Radiological evidence of measurable disease by RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment. 4. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. 5. Demonstration of lesional SSTR2 expression using an FDA-approved somatostatin receptor PET imaging agent, e.g. \[68Ga\]DOTATATE, \[64Cu\]DOTATATE, or \[68Ga\]DOTATOC, (SSTR2 positivity defined as uptake \> background liver) obtained and interpreted in accordance with product labeling and appropriate clinical use criteria within 12 months of enrollment. 6. ECOG Performance Status ≤ 1. 7. Subjects with HIV positivity are allowed if CD4 Count \> 350 cells/μL. 8. Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject the su