Trial Details

A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

NCT05636618

RECRUITING

DESCRIPTION

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

CONDITIONS

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 subject must be able to tolerate withholding long-acting SSA therapy for a minimum of 28 days and short-acting SSA therapy for a minimum of 24 hours before the first and subsequent administrations of \[203Pb\]VMT-α-NET or \[212Pb\]VMT-α-NET 9. Progressive Disease on approved therapies other than radionuclide therapy. 10. Must have clinically demonstrated adequate catecholamine blockade if catecholamine-secreting pheochromocytoma/paraganglioma tumors are present. 11. Able to understand and sign informed consent and comply with all study requirements. 12. Life expectancy \> 3 months. 13. Satisfactory organ function as determined by laboratory testing. 14. For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment, and for at least 6 months after the last dose of \[212Pb\]VMT-α-NET 15. For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception with partner and refrain from donating sperm starting from screening, during treatment, and for at least 6 months after the last dose of \[212Pb\]VMT-α-NET