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
Is NCT06479811 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including 68Ga-DOTATATE and [203Pb]VMT-alpha-NET for head and neck tumors.
Treatment: 68Ga-DOTATATE · [203Pb]VMT-alpha-NET · [212Pb]VMT-alpha-NET — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Neuroendocrine Tumor
Disease stage
Required: Stage IV, INOPERABLE
Metastatic disease required
metastatic or inoperable per Standard of Care
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — metastatic
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 participants should have received at least one line of prior therapy in the metastatic setting
Must have received: anti-PD-1 therapy — metastatic
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
as well as one agent targeting the VEGF pathway
Must have received: systemic therapy (bevacizumab, erlotinib) — metastatic
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; ANC >= 1,500/microliter; Platelets >= 100,000/microliter; Hemoglobin >= 9.0 g/dL
Kidney function
Creatinine: within normal institutional limits OR eGFR >= 60 mL/min/1.73 m^2 for participants with creatinine above institutional normal
Liver function
Total bilirubin: within normal institutional limits (<= 5x ULN if due to benign process such as Gilbert syndrome); AST/ALT <= 2.5x 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 (glomerular filtration rate (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
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