Actively Recruiting
Phase I/II Trial of Targeted Radioligand Therapy With Somatostatin-Receptor Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive Gastrointestinal Neuroendocrine Tumors and Pheochromocytoma/Paragangliomas Previously Treated With Radioligand Therapy
Led by National Cancer Institute (NCI) · Updated on 2026-03-10
66
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new targeted radioligand therapy called [212Pb]VMT-alpha-NET for adults with gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/paragangliomas (PPGL) that are metastatic or cannot be removed by surgery. These tumors have high levels of somatostatin receptors (SSTR), and this therapy combines a protein that binds to these receptors with a radioactive agent designed to kill cancer cells. The study also investigates the safety, preliminary effectiveness, and how the drug behaves in the body during retreatment for patients previously treated with systemic targeted radioligand therapy. The treatment involves intravenous infusions of [212Pb]VMT-alpha-NET given once every 8 weeks for a total of four cycles. During the first two cycles, some participants will receive a related imaging drug called [203Pb]VMT-alpha-NET a few days before treatment to help visualize drug distribution through whole-body scans. Participants may stay in the clinic for at least 4 hours after infusion and sometimes up to 48 hours for monitoring. The study includes a dose escalation phase to determine the highest tolerated dose, followed by a phase to assess response at that dose. Participants will undergo screening with physical exams, imaging scans, blood and urine tests, and heart function assessments. During treatment, weekly blood tests will monitor safety, along with imaging and laboratory evaluations to track treatment effects. After completing treatment, follow-up visits will occur regularly for up to 10 years to assess long-term safety, overall survival, and effectiveness. Researchers will measure treatment response using established imaging criteria and monitor for any side effects throughout the study period.
CONDITIONS
Brief 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
- At least one prior systemic radioligand therapy for cancer treatment
- Measurable lesion by RECIST 1.1 (phase II only)
- History of disease progression within 36 months before study drug administration
- Evidence of somatostatin receptor expression on at least 50% of visible tumor on SSTR PET scan
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function as defined by laboratory values
- Stable or treated brain metastases without progression
- HIV-positive participants must be on effective therapy with undetectable viral load
- Hepatitis B or C participants must have undetectable viral load or received curative treatment
- Willingness to stop other investigational agents 28 days before study drug
- Agreement to use effective contraception during and for 6 months after study
- Willingness to discontinue nursing during study treatment and for 6 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- 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 electrocardiogram
- Active or untreated secondary cancers except certain skin and cervical cancers
- Uncontrolled illnesses that increase risk to participant
- Progressive brain metastases or leptomeningeal disease requiring symptom control medications
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 - Approximately 24 weeks (4 cycles of 8 weeks each)
Participants receive intravenous infusions of [212Pb]VMT-alpha-NET every 8 weeks for a total of 4 cycles. A subset will receive [203Pb]VMT-alpha-NET for imaging and dosimetry prior to each cycle. Clinical laboratory evaluations, imaging studies, and blood and urine samples will be collected for safety and efficacy assessments during treatment.
4 treatment visits every 8 weeks; additional imaging and sample collection visits for some participants
Duration - Up to 10 years after treatment
After completing treatment, participants will be seen for safety and efficacy assessments approximately 30 days later, then every 12 weeks for years 1-3, every 6 months for years 4-6, and annually thereafter to assess overall survival and health status.
Visits every 12 weeks for 3 years, every 6 months for years 4-6, then annual follow-up
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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