OncoMatch/Clinical Trials/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
Official title: 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
Is NCT06479811 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including [212Pb]VMT-alpha-NET and [203Pb]VMT-alpha-NET for sinonasal neuroendocrine carcinoma.
Treatment: [212Pb]VMT-alpha-NET · [203Pb]VMT-alpha-NET · 68Ga-DOTATATE — 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 imaging with a related study drug (\[203Pb\]VMT-Alpha-NET). They will receive this drug within 30 days before each cycle. At 1, 4, 24, and 48 hours after each \[203Pb\]VMT-Alpha-NET infusion and 4 hours after each \[212Pb\]VMT-Alpha-NET infusion, they will have optional whole body scans. These scans will show where the study drug went in their body. Following treatment, participants will be invited to the NIH Clinical Center 8 weeks after the last study drug administration for an end of treatment (EOT) visit. After EOT, visits will continue every 12 weeks for years 1-3 and every 6 months for years 4-6 or until disease progression. Beyond 6 years (or disease progression), participants will be contacted yearly to assess health status for 10 years after EOT.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Neuroblastoma
Small Cell Lung Cancer
Neuroendocrine Tumor
Biomarker criteria
Required: SSTR expression (expression on at least 50% of radiographically identifiable tumor, as indicated by positive SSTR PET scan)
Evidence of somatostatin receptors (SSTR) expression on at least 50% of the radiographically identifiable...tumor, as indicated by a positive...on SSTR PET scan
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy — metastatic SCLC
SCLC: At least one prior line of standard of care systemic treatment such as chemotherapy and/or immunotherapy.
Must have received: systemic therapy — metastatic RCC
RCC participants should have received at least one line of prior therapy in the metastatic setting
Must have received: anti-PD-1 therapy — metastatic RCC
should have received at least one Programmed cell death protein 1 (PD1) / Programmed death-ligand 1 (PDL1)-targeted immune checkpoint inhibitor
Must have received: VEGFR inhibitor — metastatic RCC
should have received...one agent targeting the VEGF pathway
Must have received: systemic therapy (bevacizumab, erlotinib) — FH-deficient RCC
Participants with fumarate hydratase (FH) deficient RCC should have received at least one prior line of systemic therapy (such as bevacizumab plus erlotinib)
Cannot have received: systemic radioligand therapy
Have NOT received prior systemic radioligand therapy for definitive therapeutic purposes
Lab requirements
Blood counts
Leukocytes: 3,000/microliter; Absolute Neutrophil Count: 1,500/microliter; Platelets: 100,000/microliter; Hemoglobin >= 9.0 g/dL
Kidney function
Creatinine: within normal institutional limits OR calculated creatinine clearance (eGFR) >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal
Liver function
Total bilirubin: within normal institutional limits (<= 5 X ULN if Gilbert syndrome); AST <= 2.5 X ULN; ALT <= 2.5 X ULN
Cardiac function
QTc <= 450 ms on EKG (Framingham correction)
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 OR calculated creatinine clearance (eGFR): >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal; QTc > 450 ms on electrocardiogram (EKG) at screening. Note: Framingham correction for QTc will be used.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06479811 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic radioligand therapy disqualifies patients from enrollment.
Does this trial require SSTR?
Yes, SSTR expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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