RecruitingPhase 1NCT06479811

[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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

120 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests [212Pb]VMT-Alpha-NET, an experimental targeted radiation therapy that delivers alpha-particle radiation directly to cancer cells via a molecule that binds to a receptor found on certain tumor types. It is being tested across several rare cancer types. **You may be eligible if...** - You have confirmed metastatic or inoperable cancer of one of these types: gastrointestinal neuroendocrine tumors, pheochromocytoma/paraganglioma, small cell lung cancer, kidney cancer, or head and neck cancers (nasopharyngeal, olfactory neuroblastoma, or sinonasal neuroendocrine carcinoma) - You have received appropriate prior standard therapies for your cancer type - Your tumors are confirmed to express the target receptor **You may NOT be eligible if...** - Your cancer type is not among the eligible tumor types - You have not yet received standard treatments for your cancer - Your organ function is inadequate for the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-DOTATATE

68Ga-DOTATATE PET/CT whole-body scanning will be done at at different intervals to monitor disease.

DRUG[203Pb]VMT-alpha-NET

\[203Pb\]VMT-alpha-NET will be given IV 7 days prior to \[212Pb\]VMT-alpha-NET.

DRUG[212Pb]VMT-alpha-NET

\[212Pb\]VMT-alpha-NET will be given IV on Day 1 of every cycle for 4 cycles total at escalating doses in Phase I and at MTD during dose expansion. One cycle is 8 weeks.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06479811


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