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

Required: SSTR2 overexpression (uptake > background liver on FDA-approved somatostatin receptor PET imaging)

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)

Must have received: approved therapies other than radionuclide therapy

Progressive Disease on approved therapies other than radionuclide therapy

Cannot have received: systemic PRRT based therapies ([90Y] DOTATATE, [90Y] DOTATOC, [177Lu] DOTATATE)

Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)

Cannot have received: 90-Yttrium radioembolization

Exception: must be completed at least 6 months prior to enrollment

Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.

Cannot have received: external beam radiation therapy

Exception: must be completed at least 30 days prior to enrollment

External beam radiation therapy must be completed at least 30 days prior to enrollment.

Cannot have received: systemic anticancer therapy

Exception: must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors)

Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in subjects with functional tumors).

Cannot have received: investigational medicinal product

Exception: must be completed at least 30 days prior to anticipated treatment

Treatment with another investigational medicinal product within 30 days of anticipated treatment.

Cannot have received: major surgery

Exception: must be completed at least 30 days prior to enrollment

Major surgery must be completed at least 30 days prior to enrollment.