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Study of [212Pb]VMT-Alpha-NET for SSTR-Positive Cancers

This study is testing a new treatment called [212Pb]VMT-Alpha-NET for people with certain cancers that have a protein called somatostatin receptors (SSTRs) on their surface. These cancers include gastrointestinal neuroendocrine tumors, pheochromocytoma/paragangliomas, small cell lung cancer, kidney cancer, and some head and neck cancers (nasopharyngeal carcinoma, olfactory neuroblastoma, sinonasal neuroendocrine carcinoma). Your tumor must have spread or cannot be removed by surgery. The study aims to find the safest and most effective dose of [212Pb]VMT-Alpha-NET. You will also receive 68Ga-DOTATATE for imaging to monitor your disease.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 120 participants.
What's involved
You will receive [203Pb]VMT-alpha-NET intravenously (IV) once, 7 days before starting [212Pb]VMT-alpha-NET. Then, you will receive [212Pb]VMT-alpha-NET IV on Day 1 of every 8-week cycle, for a total of 4 cycles. You will also have 68Ga-DOTATATE PET/CT scans at different times to monitor your disease.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 3 years after the first administration of [212Pb]VMT-alpha-NET.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06479811

[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

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~120 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:68Ga-DOTATATE[203Pb]VMT-alpha-NET[212Pb]VMT-alpha-NET

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MTD of [212Pb]VMT-alpha-NET (dose escalation cohort) and safety of [212Pb]VMT-alpha-NET at the MTD (dose expansions cohorts)
Measured over DLTs through 12 weeks after initial 212Pb]VMT-alpha-NET administration (dose escalation) and all toxicities from day 1 up through 3 years (dose expansion).

Conditions

Sinonasal Neuroendocrine Carcinoma
Nasopharyngeal Carcinoma
Esthesioneuroblastoma
Olfactory Neuroblastoma
Somatostatin Receptor Positive
Small Cell Lung Cancers
Pheochromocytoma/Paragangliomas
Kidney Cancers
Head and Neck Tumors
Gastrointestinal Neuroendocrine Tumors

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NCT06479811

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • National Institutes of Health Clinical Center

    Bethesda, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Frank I Lin, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Jessica K Turner
[email protected]
(240) 858-7554
Email the study team

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Eligibility criteria

Inclusion

Participants must have histopathologically confirmed gastrointestinal neuroendocrine tumors (GI NET), pheochromocytoma/paraganglioma (PPGL), small cell lung cancers (SCLC), kidney cancers (KC), or Head \& Neck cancers (nasopharyngeal carcinoma \[NPC\], olfactory neuroblastoma \[ONB\], sinonasal neuroendocrine carcinoma \[SNEC\]) that are metastatic or inoperable per Standard of Care. Note: for KC, all histopathologies of kidney cancers are eligible as long as it is a primary renal neoplasm.
Required prior therapies:
GI NET, PPGL, H\&N: no specific prior therapy is needed.
SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and/or immunotherapy.
KC: Renal cell carcinoma (RCC) participants should have received at least one line of prior therapy in the metastatic setting and should have received at least one Programmed cell death protein 1 (PD1) / Programmed death-ligand 1 (PDL1)-targeted immune checkpoint inhibitor as well as one agent targeting the VEGF pathway. Participants with fumarate hydratase (FH) deficient RCC should have received at least one prior line of systemic therapy (such as bevacizumab plus erlotinib). No prior therapy is needed for participants with other histologic subtypes.
Have NOT received prior systemic radioligand therapy for definitive therapeutic purposes. Prior external beam radiation therapy is allowed.
History of disease progression by imaging (e.g., 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% 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/microliter
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
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.
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 up to 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

Any investigational agents should be stopped at least 28 days prior to the first dose of \[203Pb\]VMT-Alpha-NET.
Systemic therapy should be stopped at least 28 days prior to the first dose of \[203Pb\]VMT-Alpha-NET (participants with prior systemic therapies for their malignancy only, except participants with SCLC).
Systemic therapy should be stopped at least 14 days prior to the first dose of \[203Pb\]VMT-Alpha-NET (participants with SCLC only).
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 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.

What this trial measures

  • MTD of [212Pb]VMT-alpha-NET (dose escalation cohort) and safety of [212Pb]VMT-alpha-NET at the MTD (dose expansions cohorts)DLTs through 12 weeks after initial 212Pb]VMT-alpha-NET administration (dose escalation) and all toxicities from day 1 up through 3 years (dose expansion).

    The MTD will be presented as a recommended dose to be used in Dose Expansion Part for each disease group being studied.Descriptive tabulations of toxicity will be provided in Dose Expansion Part, along with the agent attribution determination and CTCAE grade for each toxicity event. The data will be presented as an absolute count of the event at a participant level as well as a percentage of total evaluable participants.