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[212Pb]VMT-alpha-NET / Esthesioneuroblastoma / Nasopharyngeal Carcinoma · Phase 1 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 dose-escalation and expansion trial of [212Pb]VMT-alpha-NET, a lead-212 radiopharmaceutical targeting somatostatin receptors, currently recruiting participants with metastatic or inoperable SSTR-positive malignancies across multiple sites. The trial aims to establish maximum tolerated dose and safety profile; no efficacy data or interim results are reported in this registry record.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Sinonasal Neuroendocrine Carcinoma, Nasopharyngeal Carcinoma, Esthesioneuroblastoma, Olfactory Neuroblastoma, Somatostatin Receptor Positive, Small Cell Lung C…; age from 18 Years; to 120 Years. Intervention: 1/Dosimetry Arm 1; 2/Arm 2; 3/Arm 3. n = 120. 1 site: United States.
This is a Phase 1 dose-escalation and expansion trial of [212Pb]VMT-alpha-NET, a lead-212 radiopharmaceutical targeting somatostatin receptors, currently recruiting participants with metastatic or inoperable SSTR-positive malignancies across multiple sites. The trial aims to establish maximum tolerated dose and safety profile; no efficacy data or interim results are reported in this registry record.
Primary outcomes are MTD and safety only; tumor response is not listed as a primary endpoint
Clinicians should understand that this Phase 1 trial is enrolling but has not yet reported efficacy or safety data. Once results become available, they will inform whether [212Pb]VMT-alpha-NET warrants Phase 2 evaluation in SSTR-positive malignancies.
Phase 1 dose-escalation and expansion trial of a novel targeted radiopharmaceutical in multiple somatostatin-receptor–positive cancers; no results reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should understand that this Phase 1 trial is enrolling but has not yet reported efficacy or safety data. Once results become available, they will inform whether [212Pb]VMT-alpha-NET warrants Phase 2 evaluation in SSTR-positive malignancies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06479811). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). 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. Interventions: DRUG: 68Ga-DOTATATE; DRUG: [203Pb]VMT-alpha-NET; DRUG: [212Pb]VMT-alpha-NET. Primary outcome 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).. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.