Tests a radioactive drug targeting SSTR in advanced neuroendocrine tumors
Tests a radioactive drug that targets SSTR in adults with advanced tumors.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Bethesda, United StatesSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose gastrointestinal neuroendocrine tumor or pheochromocytoma/paraganglioma has spread or cannot be removed by surgery, and who already had radioligand therapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Confirmed gastrointestinal neuroendocrine tumor (GI NET) or pheochromocytoma/paraganglioma (PPGL) that has spread (metastatic) or cannot be removed by surgery. The tumor must have shown worsening on scans or by symptoms in the past 36 months, and at least 50 percent of the visible tumor must take up the SSTR scan tracer. In phase II, at least 1 lesion must be measurable by RECIST 1.1.
- Earlier treatment
- Must have had at least 1 earlier systemic radioligand therapy. Earlier external beam radiation is also allowed if they had at least 1 systemic radioligand therapy. Other investigational drugs must be stopped at least 28 days before the first dose of [203Pb]VMT-alpha-NET.
- Biomarker or test result
- Somatostatin receptor (SSTR) positive tumor on an SSTR PET scan, with SSTR uptake on at least 50 percent of the tumor visible on CT or MRI.
Main reasons for not taking part
- Past allergic reaction to compounds similar to VMT-alpha-NET
- Positive pregnancy test at screening
- QTc above 450 ms on the heart tracing (EKG) at screening
- Active or untreated second cancer (except nonmelanoma skin cancer and carcinoma in situ of the cervix)
- Uncontrolled other illness that could raise the risk for the participant
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT06427798, who can take part
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT06427798
- Record updated
- 16 October 2026
- Original description
Background:Read full original descriptionShow less
Phase I/II Trial of Systemic Targeted Radioligand Therapy (TRT) With Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive (SSTR+) Gastrointestinal (GI) Neuroendocrine Tumors (NET) and Pheochromocytoma/Paragangliomas Previously Treated With Systemic Radioligand Therapy
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....
Exclusion: History of allergic reactions attributed to compounds of similar chemical or biologic composition to VMT-alpha-NET; 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; 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.
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.