NCT06148636

A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors

A Phase 1, First-in-human Clinical Trial of [212Pb] VMT-alpha-NET Using a Forward Dosimetric Planning Technique to Treat Refractory or Relapsed Neuroendocrine Tumors

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: David Bushnell · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.

Detailed description

This research study is designed to explore if a new radiotherapeutic (radioactive) drug, named 212Pb (212-lead) VMT-α-NET, works against neuroendocrine tumor cells. To begin researching this drug, we need to determine if \[212Pb\] VMT-α-NET is safe and tolerable when used as a cancer treatment. As a safety study, it is unknown if the treatment is safe or effective. The study will also estimate the radiation dose to the kidneys for this treatment. To calculate this radiation dose, imaging is also performed with the sister drug, \[203Pb\] VMT-α-NET using SPECT/CT imaging. Each participant is assigned a radiation dose to the kidneys that cannot be exceeded. The study is testing the safety of the specific radiation dose to the kidneys when using \[212Pb\] VMT-α-NET. Participants are assigned a radiation dose based on how other participants have tolerated the \[212Pb\] VMT-α-NET. The amount of \[212Pb\] VMT-α-NET administered varies person-to-person because of each person's unique tumor uptake of \[203Pb\] VMT-α-NET and how long it lasts in the body. The study involves 2 treatments, about 8 to 10 weeks apart. The drug is given by infusion once per treatment. The participants also receive an infusion of amino acids to help protect the kidneys as well as medications to help protect against nausea (feeling sick to the stomach). Once a participant is administered the \[212Pb\] VMT-α-NET, they must be followed (i.e. come back to the clinic) for at least 6 months for safety assessments. Safety assessments include blood tests to check bone marrow, kidney, and liver function as well as urinary tests to check kidney function. Participants will also have imaging at 6 months post-treatment to measure how their tumors responded to therapy. Participants will have lifelong follow-up for this study.

Conditions

• Neuroendocrine Tumors
• Neuroendocrine Tumor of the Lung
• Neuroendocrine Tumor Grade 1
• Neuroendocrine Tumor Grade 2
• Neuroendocrine Tumor of Pancreas

Interventions

Type	Name	Description
DRUG	[212Pb] VMT-α-NET	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.
DIAGNOSTIC_TEST	[203Pb] VMT-α-NET SPECT/CT	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.

Timeline

• Start date: 2023-11-10
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2023-11-28
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study