NCT05636618 · Perspective Therapeutics
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Neuroendocrine Tumors
What this study is about
This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
View original scientific description
This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors
Interventions
DRUG
[203Pb]VMT-α-NET
\[203Pb\]VMT-α-NET is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
DRUG
[212Pb]VMT-α-NET
\[212Pb\]VMT-α-NET is administered by intravenous infusion for treatment of SSTR2 expressing tumors.
Primary outcome measures
Number of participants with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT-α-NET
Time frame: Incidence and severity of DLTs during the first 42 days of study treatment will be assessed.
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
Time frame: Up to week 96
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
Time frame: Up to week 96
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)
Time frame: Until the end of study (3 years after end-of-study visit)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult (ages ≥18) PRRT-naïve subjects with NETs by local pathology. 2. Locally advanced/unresectable or metastatic NETs. 3. Radiological evidence of measurable disease by RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment. 4. Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. 5. Demonstration of lesional SSTR2 expression using an FDA-approved somatostatin receptor PET imaging agent, e.g. \[68Ga\]DOTATATE, \[64Cu\]DOTATATE, or \[68Ga\]DOTATOC, (SSTR2 positivity defined as uptake \> background liver) obtained and interpreted in accordance with product labeling and appropriate clinical use criteria within 12 months of enrollment. 6. ECOG Performance Status ≤ 1. 7. Subjects with HIV positivity are allowed if CD4 Count \> 350 cells/μL. 8. Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject the s
Where
- Jacksonville, Florida
- Miami, Florida
- Chicago, Illinois
- Iowa City, Iowa
- Lexington, Kentucky
- Baltimore, Maryland
- Detroit, Michigan
- Grand Rapids, Michigan
- Troy, Michigan
- Rochester, Minnesota
- St Louis, Missouri
- Omaha, Nebraska
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations