Actively Recruiting
Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new cancer treatment called [212Pb]VMT-Alpha-NET for tumors that have somatostatin receptors (SSTRs) on their surface. These tumors include those found in the lungs, head and neck, digestive tract, kidneys, and adrenal glands. The study focuses on people with tumors that have spread and cannot be removed by surgery. The goal is to find the highest safe dose of this drug and evaluate its safety and effects on these cancers. The treatment involves giving [212Pb]VMT-Alpha-NET through a vein on the first day of each 8-week cycle, for a total of four cycles. Some participants will also receive a related imaging drug, [203Pb]VMT-Alpha-NET, a few days before the first two cycles to track where the drug travels in the body using scans. After each dose, participants will stay in the hospital for a few nights and have weekly blood tests during each cycle. Participants will have physical exams, blood and urine tests, heart function tests, and imaging scans before and during the study. Researchers will monitor safety, drug effects, and tumor response through scans, lab tests, and questionnaires. Follow-up visits will continue for up to six years after the last treatment to check on long-term outcomes and overall health.
CONDITIONS
Brief Title
[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed gastrointestinal neuroendocrine tumors, pheochromocytoma/paraganglioma, small cell lung cancer, kidney cancer, or specific head and neck cancers that are metastatic or inoperable.
- Age 18 years or older.
- ECOG performance status of 0 or 1, indicating the ability to carry out daily activities with minimal limitation.
- No prior systemic radioligand therapy for their cancer.
- Evidence of somatostatin receptor expression on at least 50% of tumor tissue shown by PET scan.
- Adequate organ and marrow function as defined by specific blood counts and laboratory tests.
- History of disease progression within the past 36 months.
- Participants with treated or stable brain metastases are eligible.
- Participants with HIV, hepatitis B, or hepatitis C must meet specific viral load and treatment criteria.
- Individuals of child-bearing potential must agree to effective contraception during and 6 months after the study.
- Willingness and ability to provide informed consent.
You will not qualify if you...
- Use of any investigational agents within 28 days before starting the study drug.
- Systemic therapy stopped less than 28 days before starting the study drug, except for small cell lung cancer patients where 14 days is required.
- History of allergic reactions to similar compounds as the study drug.
- Positive pregnancy test in individuals of child-bearing potential.
- QTc interval greater than 450 milliseconds on EKG.
- Active or untreated secondary cancers, except certain skin and cervical cancers.
- Uncontrolled illnesses or conditions that increase risk during the study.
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 screening and enrollment visit
Duration - Approximately 24 weeks (4 cycles of 8 weeks each)
Participants receive [212Pb]VMT-Alpha-NET intravenously every 8 weeks for a total of 4 administrations. Some participants will receive [203Pb]VMT-Alpha-NET one week prior to each treatment cycle for imaging and dosimetry assessments. Clinical laboratory evaluations, imaging studies, and collection of blood and urine samples are performed during treatment to assess safety and efficacy.
4 treatment visits every 8 weeks with additional imaging and sample collection visits depending on cohort
Duration - Up to 3 years with annual contact thereafter
After completing treatment, participants will be seen approximately 30 days later, then every 12 weeks for 3 years for safety and efficacy assessments. After 3 years, participants will be contacted annually to assess overall survival and health status.
Visits every 12 weeks for 3 years, then annual contact
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Joy H Zou, R.N.
F
Frank I Lin, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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