This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology.
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.
For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)
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.
Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-α-NET.
Known additional malignancy that is progressing or requires active treatment.
Pregnancy or breastfeeding a child.
Febrile illness within 48 hours of any scheduled [212Pb]VMT-α-NET administration should be rescheduled > 48 hours after resolution of fever].
Sequential
[203Pb]VMT-α-NET
Drug\[203Pb\]VMT-α-NET is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
[212Pb]VMT-α-NET
Drug\[212Pb\]VMT-α-NET is administered by intravenous infusion for treatment of SSTR2 expressing tumors.
Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-α-NET
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 in subjects with NETs
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of \[212Pb\]VMT-α-NET
ORR per Response Assessment in Neuro-Oncology (RANO) meningioma criteria in subjects with meningioma
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of \[212Pb\]VMT-α-NET
Number of subjects with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered \[212Pb\]VMT-α-NET and which does not necessarily have a causal relationship with this treatment. Associated Adverse Events (AE) or Serious AEs are assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Anti-tumor efficacy of [212Pb]VMT-α-NET in terms of tumor response
Determination of the best overall response rate (BOR) by RECIST v1.1 in subjects with neuroendocrine tumors or RANO in meningioma subjects
Determine the duration of response (DOR) receiving [212Pb]VMT-α-NET.
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading determined by RECIST v1.1 or RANO
Determination of Progression-free survival (PFS)
PFS is how long a subject lives without the disease worsening as evaluated by RECIST v1.1 or RANO
To investigate the Overall Survival (OS) following treatment with [212Pb]VMT-α-NET
OS is how long a subject lives after a subject starts treatment
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