Actively Recruiting
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy
Led by National Cancer Institute (NCI) · Updated on 2026-03-10
66
Participants Needed
1
Research Sites
751 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR. Objective: To test a drug (\[212Pb\]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells. Eligibility: Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function. \[212Pb\]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may need to stay in the hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of 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 for 10 years....
CONDITIONS
Official Title
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/paraganglioma (PPGL) that are metastatic or inoperable
- Received at least one prior systemic radioligand therapy
- At least one measurable lesion by RECIST 1.1 (Phase II only)
- Disease progression within the past 36 months by imaging or clinical symptoms
- Somatostatin receptor expression on at least 50% of tumor visible by imaging
- Age 18 years or older
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as defined by specific blood counts and liver and kidney function
- Participants with treated brain metastases may participate if no progression is detected
- Participants with asymptomatic new or progressive brain metastases or leptomeningeal disease not requiring symptom medication
- HIV-positive participants must be on effective therapy with undetectable viral load
- Hepatitis B-positive participants must have undetectable viral load
- Hepatitis C-positive participants must have received curative treatment and have undetectable viral load
- Must stop other investigational agents at least 28 days before study drug administration
- Agreement to use effective contraception during study and for 6 months after last dose
- Willingness to discontinue nursing from start of treatment through 6 months after last dose
- Ability and willingness to provide informed consent
You will not qualify if you...
- Allergic reactions to compounds similar to VMT-alpha-NET
- Positive pregnancy test for individuals of child-bearing potential
- QTc interval greater than 450 ms on electrocardiogram
- History or current active/untreated secondary malignancy except certain skin and cervical cancers
- Uncontrolled illness or conditions increasing participant risk as determined by medical history and exam
AI-Screening
AI-Powered Screening
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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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