Brain Cancers
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Phase 1 Trials
Brain Cancers
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VICC-DTPHI23045
Ph I/IIa Study of [212Pb]VMT-a-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 + Tumors
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Key Eligibility Criteria:
Inclusion Criteria:
1. Adult PRRT-naïve subjects with NETs or meningioma by local pathology
2. Disease described clinically as:
(a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study
(b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study
(c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma.
3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3)
4. Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
5. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior to enrollment.
6. Demonstration of lesional SSTR expression:
(a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. [68Ga]DOTATATE, [64Cu]DOTATATE, or [68Ga]DOTATOC (b) For meningioma: using a standard-of-care SSTR PET imaging agent within 45 days of enrollment
Exclusion Criteria:
1. Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-a-NET.
2. Known additional malignancy that is progressing or requires active treatment.
3. Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)
4. Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
5. For Subjects with NETs: 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.
6. QTc > 450 milliseconds for males and females.
For internal pre-screening, please contact: Epic message basket- VICC RESEARCH PHASE 1
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