New radioactive drug targets Hard-to-Treat gut and adrenal tumors
NCT ID NCT06427798
First seen Jun 24, 2026 · Last updated Aug 19, 2026 · Updated 7 times
Summary
This study tests a new radioactive drug, [212Pb]VMT-alpha-NET, in people with advanced gastrointestinal neuroendocrine tumors or pheochromocytoma/paragangliomas that have already been treated with radiation therapy. The drug is designed to attach to a protein on the surface of these tumor cells and deliver radiation directly to them. The trial has two phases: the first finds the best dose, and the second checks how well it works. Participants receive up to four cycles of treatment, each 8 weeks apart, and are followed for up to 10 years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [212Pb]VMT-alpha-NET (a radioactive drug that targets somatostatin receptors on tumor cells)
- What this could lead to
- If successful, this could provide a new treatment option for people with advanced GI neuroendocrine tumors or pheochromocytoma/paragangliomas who have already tried other radiation therapies.
- What could go wrong
- This is an early-phase trial with only 66 participants, so it is not yet known if the drug is effective or safe. The treatment involves radioactivity, which can cause side effects like damage to healthy tissues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jul 2039
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET) or pheochromocytoma/paraganglioma (PPGL) cancers that are metastatic or inoperable per Standard of Care. * Have received at least 1 prior systemic radioligand therapy for definitive therapeutic purposes. Note: Participants with prior external beam radiation treatment (EBRT) will also be eligible as long as they have had at least 1 prior administration of a systemic radioligand therapy. * Must have at least 1 measurable lesion by RECIST 1.1 (phase II only). * History of progression by imaging per RECIST 1.1 or clinically (defined as increase in severity or frequency of symptoms related to disease) within the past 36 months prior to the first dose of \[203Pb\]VMT-alpha-NET. * Evidence of somatostatin receptors (SSTR) expression on at least 50 percent of the radiographically identifiable (i.e., visible on an anatomic scan such as CT or magnetic resonance imaging \[MRI\]) tumor, as indicated by a positive (uptake qualitatively identifiable as above the local background) on SSTR PET scan. * Age \>= 18 years. * ECOG performance status \<= 1. * Participants must have adequate organ and marrow function as defined below: * Leukocytes: 3,000/microliter * Absolute Neutrophil Count: 1,500/microliter * Platelets: 100,000/miroliter * Hemoglobin: \>= 9.0 g/dL * Total bilirubin: within normal institutional limits. Note: \<= 5 X institutional upper limit of normal (ULN) if bilirubin elevation is due to a benign process such as Gilbert syndrome * AST: \<= 2.5 X institutional ULN * ALT: \<= 2.5 X institutional ULN * Creatinine: within normal institutional limits OR * Calculated creatinine clearance (glomerular filtration rate (eGFR): \>= 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal * Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression at screening. * Participants with new or progressive brain metastases or leptomeningeal disease are eligible as long as the participant is asymptomatic and not requiring medication for symptom control from the brain lesions at screening. * Participants seropositive for human immunodeficiency virus (HIV) must: * be on effective anti-retroviral therapy; and * have an undetectable viral load at screening. * Participants seropositive for hepatitis B virus (HBV), must have HBV viral load undetectable at screening. -Participants seropositive for hepatitis C virus (HCV) must: * received curative treatment; and * have an undetectable HCV viral load at screening. * Participants may enroll in this study while on another therapeutic trial in order to start the screening process. However, all other investigational agents should be stopped at least 28 days prior to receiving \[203Pb\]VMT-alpha-NET. * Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) at study entry and at least 6 months after the last dose of the study agent(s). * Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study agents. * The ability of the participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-alpha-NET. * Positive Beta human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in i IOCBP at screening. * QTc \> 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used. * History of or detection at screening of active/untreated secondary malignancy except nonmelanoma skin cancer and carcinoma in situ of the uterine cervix. * Uncontrolled intercurrent illness, factors, evaluated by medical history and physical exam which would potentially increase in the risk of the participant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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