Actively Recruiting
[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
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Some cancers have high levels of proteins called somatostatin receptors (SSTRs) on the surface of the tumors. These tumors can be in the lung, head and neck, digestive tract, kidneys, and in or near the adrenal glands. Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors. Objective: To test a study drug (\[212Pb\]VMT-Alpha-NET) in people with tumors that have SSTRs. Eligibility: People aged 18 years and older with tumors of the lung, kidneys, head and neck, digestive tract, or adrenal glands that have SSTRs. Their tumors must have spread to other organs and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. A sample of tumor tissue may be collected if one is not already available. \[212Pb\]VMT-Alpha-NET is given through a tube attached to a needle inserted into a vein. The drug will be given on the first day of four 8-week cycles. Participants will stay in the hospital for a few nights after each dose. They will have blood tests once a week during each cycle. Some participants will also get a related study drug (\[203Pb\]VMT-Alpha-NET). They will receive this drug a few days before the first 2 cycles. At 4, 24, and 48 hours after each infusion, they will have whole body scans. These scans will show where the study drug went in their body. Follow-up visits will continue up to 6 years after the last treatment.
CONDITIONS
Official 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...
- Adults aged 18 years or older
- Histologically confirmed metastatic or inoperable gastrointestinal neuroendocrine tumors, pheochromocytoma/paraganglioma, small cell lung cancers, kidney cancers, or specific head and neck cancers
- No prior systemic radioligand therapy
- ECOG performance status of 0 or 1
- Evidence of somatostatin receptor expression on at least 50% of tumor visible on imaging
- Adequate organ and marrow function as defined by specific blood counts and liver and kidney function
- For kidney cancer, prior therapies vary by subtype, with some requiring previous treatments
- Participants with treated brain metastases without progression or asymptomatic brain metastases not requiring medication
- HIV-positive participants must be on effective therapy with undetectable viral load
- HBV-positive participants must have undetectable viral load
- HCV-positive participants must have completed curative treatment and have undetectable viral load
- Use of effective contraception during and for 6 months after study
- Willingness to stop nursing during the treatment and for 6 months after
- Ability and willingness to provide informed consent
You will not qualify if you...
- Use of investigational agents within 28 days before starting study drug
- Systemic therapy stopped less than 28 days prior (14 days for small cell lung cancer)
- History of allergic reactions to compounds similar to VMT-Alpha-NET
- Positive pregnancy test in individuals of child-bearing potential
- QTc interval greater than 450 ms on EKG
- Active or untreated secondary cancers except certain skin and cervical cancers
- Uncontrolled illnesses that increase risk as judged by medical evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
F
Frank I Lin, M.D.
CONTACT
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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