Actively Recruiting
Phase 1 Study of 212PbVMT-Alpha-NET for Treating Advanced Somatostatin-Receptor Positive Gastrointestinal, Lung, Kidney, and Head and Neck Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-06-12
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying tumors that have somatostatin receptors SSTRs on their surface, which include tumors in the lung, head and neck, digestive tract, kidneys, and adrenal glands. This trial tests a drug called 212PbVMT-Alpha-NET, which is designed to target these receptors and potentially help shrink tumors that have spread and cannot be removed surgically. The study focuses on people aged 18 and older with these specific types of tumors and aims to determine the maximum tolerated dose and safety of the drug. Participants receive 212PbVMT-Alpha-NET through a vein on the first day of four 8-week cycles. Some participants will also receive a related imaging drug, 203PbVMT-Alpha-NET, a few days before the first two treatment cycles to allow whole-body scans that track how the drug spreads in the body. After each infusion, participants stay in the hospital for a few nights and have weekly blood tests during each treatment cycle. The study includes dose escalation to find the best dose and then dose expansion at that dose level. Throughout the study, participants undergo physical exams, blood and urine tests, imaging scans including PETCT and SPECTCT, heart function tests, and may provide tumor tissue samples if needed. Follow-up visits occur about 30 days after treatment ends, then every 12 weeks for up to 3 years, with annual check-ins continuing up to 6 years after the last treatment. Researchers monitor safety, response to treatment, and survival outcomes during this time.
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...
- Adults aged 18 years or older
- Histopathologically confirmed GI neuroendocrine tumors, pheochromocytoma/paraganglioma, small cell lung cancer, kidney cancer, or specific head and neck cancers that are metastatic or inoperable
- No prior systemic radioligand therapy
- ECOG performance status of 0 or 1
- Evidence of somatostatin receptor expression on at least 50% of tumor sites
- Adequate organ and marrow function as defined by blood counts and lab values
- For kidney cancer: prior therapies required depending on subtype
- HIV positive participants must be on effective therapy with undetectable viral load
- HBV and HCV positive participants must have undetectable viral load or completed curative treatment
- Agree to use effective contraception or be not of childbearing potential
- Willingness and ability to provide informed consent
You will not qualify if you...
- Use of investigational agents within 28 days before the first dose
- Systemic therapy stopped less than 28 days (or 14 days for small cell lung cancer) before first dose
- Allergic reactions to compounds similar to VMT-Alpha-NET
- Positive pregnancy test in individuals who can bear children
- QTc interval greater than 450 ms on EKG
- Active or untreated secondary cancers except certain skin and cervix cancers
- Uncontrolled illnesses that increase participant risk
Research Team
J
Jessica K Turner
F
Frank I Lin, M.D.
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