Actively Recruiting
A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
Led by Perspective Therapeutics · Updated on 2026-05-14
300
Participants Needed
19
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new targeted alpha-particle therapy called [212Pb]VMT-α-NET for adults with advanced tumors that express somatostatin receptor type 2 (SSTR2), such as neuroendocrine tumors, meningioma, pheochromocytoma, and paragangliomas. This Phase I/IIa study aims to find the optimal dose and assess safety and preliminary effectiveness in patients whose tumors cannot be removed or have spread, who have not previously received peptide receptor radionuclide therapy (PRRT). The study has two parts: Part 1 focuses on dose finding, where participants receive up to four intravenous infusions of [212Pb]VMT-α-NET about 8 weeks apart to determine the best biological dose. A dosimetry sub-study using [203Pb]VMT-α-NET is included to evaluate radiation distribution before treatment. Part 2 enrolls up to 100 participants with specific tumor types to receive the recommended dose for further safety and preliminary efficacy assessment. Reno-protective amino acids are given before each treatment to protect kidney function. Participants will undergo imaging scans, laboratory tests, and evaluations of tumor response using established criteria during treatment and follow-up, which can last up to three years after the last study visit. Researchers will monitor dose-limiting toxicities, adverse events, tumor response rates, progression-free survival, and overall survival. Pharmacokinetics of the therapy will also be studied to understand how the drug behaves in the body.
CONDITIONS
Brief Title
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged 18 years or older with neuroendocrine tumors or meningioma confirmed by local pathology
- Tumors must be locally advanced, unresectable, or metastatic
- Must be peptide receptor radionuclide therapy (PRRT)-naïve
- For meningioma, histologically confirmed diagnosis of any grade per WHO CNS5 classification
- Measurable disease by RECIST v1.1 for NETs or RANO criteria for meningioma within specified timeframes
- Evidence of disease progression within 12 months prior to enrollment
- Demonstrated somatostatin receptor expression on PET imaging using FDA-approved agents
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- HIV positive subjects allowed if CD4 count is above 350 cells/μL
- Ability to tolerate withholding long-acting somatostatin analog therapy for at least 28 days before treatment
- Progressive disease on approved therapies other than radionuclide therapy for NETs
- For meningioma patients on corticosteroids, dose must be at or below 4 mg/day dexamethasone or equivalent
- Adequate catecholamine blockade for catecholamine-secreting tumors
- Able to understand and sign informed consent
- Life expectancy greater than 3 months
- Satisfactory organ function by laboratory testing
- Agreement to use effective contraception for females of reproductive potential during and up to 6 months after treatment
- Agreement to use contraception for males of reproductive potential during and up to 6 months after treatment
You will not qualify if you...
- Known hypersensitivity to somatostatin analogs, somatostatin receptor imaging agents, or components of [212Pb]VMT-α-NET
- Presence of another active malignancy requiring treatment
- Pregnancy or breastfeeding
- Febrile illness within 48 hours before [212Pb]VMT-α-NET administration
- Participation in another investigational drug study within 30 days prior to treatment
- Prior systemic PRRT or 90-Yttrium radioembolization within 6 months
- External beam radiation therapy must be completed at least 30 days before enrollment
- Radiation absorbed dose to critical organs must be documented if prior radiotherapy was received
- Prior systemic anticancer therapy must be completed at least 30 days before enrollment, except for somatostatin analogs
- Major surgery completed at least 30 days before enrollment
- Known brain metastases unless treated and stable for 6 months and off steroids for 14 days
- Active infections requiring treatment within 3 days prior to enrollment
- Receipt of live attenuated vaccines within 7 days prior to enrollment
- Severe nausea, vomiting, or diarrhea within 72 hours before first dose despite supportive care
- Medical conditions posing unreasonable hazard
- History of severe allergic reactions to investigational product components
- Current abuse of alcohol or illicit drugs
- Any medical or social issues that could interfere with study conduct or radiation safety
- QTc interval greater than 450 milliseconds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo dosimetric evaluation using [203Pb]VMT-α-NET to assess radiation dose distribution before treatment.
1 visit (in-person)
Duration - Approximately 24 weeks
Participants receive up to 4 administrations of [212Pb]VMT-α-NET by intravenous infusion approximately 8 weeks apart, along with co-administration of reno-protective amino acids before each dose.
Up to 4 treatment visits approximately 8 weeks apart
Duration - Up to 3 years
Participants are monitored for safety, adverse events, and treatment efficacy for up to 3 years after the last treatment.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 19 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Biogenix Molecular
Miami, Florida, United States, 33165
Actively Recruiting
3
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
6
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
8
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
9
Michigan Health Professionals
Troy, Michigan, United States, 48098
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
13
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
14
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
15
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
16
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
17
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
19
Froedtert Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
C
ClinicalTrials at Perspectivetherapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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