Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Neuroendocrine Tumors

Exclusion Criteria

• •1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of \[212Pb\]VMT-α-NET.
• •2. Active secondary malignancy.
• •3. Pregnancy or breastfeeding a child.
• •4. Febrile illness within 48 hours of any scheduled \[212Pb\]VMT-α-NET administration should be rescheduled \> 48 hours after resolution of fever\].
• •5. Treatment with another investigational medicinal product within 30 days of anticipated treatment.
• •6. Prior treatment with systemic PRRT based therapies (i.e., \[90Y\] DOTATATE/DOTATOC or \[177Lu\] DOTATATE)
• •7. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
• •8. External beam radiation therapy must be completed at least 30 days prior to enrollment.
• •9. Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors).
• •10. Major surgery must be completed at least 30 days prior to enrollment.
• •11. Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.
• •12. Recently diagnosed and active infections requiring a time-limited course of antifungals or antibiotics in the 3 days prior to enrollment.
• •13. Receipt of live attenuated vaccines in the 7 days prior to enrollment.
• •14. Grade 3 nausea/vomiting or diarrhea within 72 hours before the of first scheduled dose of \[212Pb\]VMT-α-NET despite adequate antiemetic and other supportive care
• •15. Known medical condition which would make this protocol unreasonably hazardous for the subject.
• •16. Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the Investigational Medicinal Product or excipients.
• •17. Current abuse of alcohol or illicit drugs (exclusive of use of medically prescribed cannabinoids).
• •18. Existence of any medical or social issues likely to interfere with study conduct or that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions.
• •19. QTc \> 450 milliseconds for males and females.