Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [203Pb]VMT-α-NET, [212Pb] VMT-α-NET
VMT-α-NET · 3 trials · 12 indications
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of \[212Pb\]VMT-α-NET
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of \[212Pb\]VMT-α-NET
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.
percentage of lesions detected with \[203Pb\]VMT-α-NET compared to the gold standard of NetSPOT or Ga-68 DOTATOC.
Determine the recommended phase 2 dose for therapy with \[212Pb\]VMT-Α-NET administered intravenously to patients with neuroendocrine tumors that have progressed despite therapy.
| Arm | Type | Description |
|---|---|---|
| Dose Finding | EXPERIMENTAL | Dose Finding to determine OBD and potential RP2D in up to 200 patients receiving up to 4 administrations of \[212Pb\]VMT-α-NET approximately 8 weeks apart. A dosimetry sub-study utilizing \[203Pb\]VMT-α-NET is incorporated into the study. |
| Dose Expansion | EXPERIMENTAL | Dose up to 100 subjects (gastroenteropancreatic NETs, bronchial NETs, and pheochromocytoma or paraganglioma and meningioma) at RP2D for further assessment of safety and preliminary efficacy. |
| [203Pb]VMT-α-NET SPECT/CT | EXPERIMENTAL | injection of \[203Pb\]VMT-α-NET with serialized imaging and dosimetry measurements |
| -1 Dose Level | EXPERIMENTAL | This dose level is used if the starting dose level is deemed to have unacceptable toxicity. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 200 cGy. |
| Cohort 1 | EXPERIMENTAL | This is the starting dose level for participants. Participants are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 350 cGy. |
| Cohort 2 | EXPERIMENTAL | If the participants from Cohort 1 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 600 cGy. |
| Cohort 3 | EXPERIMENTAL | If the participants from Cohort 2 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 810 cGy. |
| Cohort 4 | EXPERIMENTAL | If the participants from Cohort 3 tolerate therapy, new participants are enrolled and are prescribed \[212Pb\] VMT-α-NET with the total radiation dose to kidneys not to exceed 1050 cGy. |
| Name | Type | Description |
|---|---|---|
| [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. |
| SPECT/CT | DEVICE | Scans are administered over 3 days: 1 hour post injection, 4 to 8 hours post-injection, 24 to 30 hours post-injection, and 42 to 52 hours post-injection. |
| [212Pb] VMT-α-NET | DRUG | Up to 2 infusions with \[212Pb\] VMT-α-NET, each infusion separated by at least 8 weeks. During each infusion, the participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage. |
| [203Pb] VMT-α-NET SPECT/CT | DIAGNOSTIC_TEST | The \[203Pb\] VMT-α-NET SPECT/CT is performed for all participants to determine trial eligibility as well as for the calculations to determine the estimated radiation dose to kidneys. This involves three imaging sessions of about 2 hours each over 2 days. The participants also receive an infusion with lysine and arginine (amino acids) to help reduce kidney damage at the time they receive the injection of . \[203Pb\] VMT-α-NET, a radioactive tracer drug. |
Inclusion Criteria: 1. Adult (ages ≥18) 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 NET...
VMT-α-NET is an investigational therapy being studied for neuroendocrine tumors, including grade 2 and unresectable neuroendocrine tumors. It is also being evaluated in related SSTR2-positive tumors such as gastroenteropancreatic, bronchial, and pancreatic neuroendocrine tumors, paraganglioma, pheochromocytoma, and meningioma. It has not been approved for any use.
VMT-α-NET targets somatostatin receptor type 2, or SSTR2. It is a small molecule designed to bind SSTR2, which is overexpressed on many neuroendocrine tumors, allowing targeted delivery of alpha-emitting isotopes. The program pairs the imaging isotope lead-203 with the therapeutic isotope lead-212.
VMT-α-NET is being developed by Perspective Therapeutics, Inc., which trades under the ticker CATX. The company is advancing the asset as a targeted alpha-particle therapy for SSTR2-positive tumors, with clinical activity conducted at sites in the United States.
VMT-α-NET is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes early-phase and Phase 1 studies, with one trial listed as recruiting and others active but not recruiting.
VMT-α-NET is being studied in NCT06148636, a safety study of 212Pb-VMT-alpha-NET in patients with neuroendocrine tumors; NCT05636618, a Phase 1 trial of targeted alpha-particle therapy for advanced SSTR2-positive tumors; and NCT05111509, a first-in-human trial of an alpha-radiation imaging agent.
Yes. VMT-α-NET refers to the same program as [203Pb]VMT-α-NET and [212Pb]VMT-α-NET. The bracketed prefixes denote the radioisotope used: lead-203 for imaging and lead-212 for targeted alpha-particle therapy. Both are studied under the VMT-α-NET name.