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NCT06479811 · ClinicalTrials.gov registry record · Phase 1
[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
A Phase 1 study of Kidney Cancers and Somatostatin Receptor Positive, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06479811: Recruiting Phase 1 study of Kidney Cancers and Somatostatin Receptor Positive, sponsored by National Cancer Institute (NCI).
NCT06479811 is a Phase 1 study of Kidney Cancers and Somatostatin Receptor Positive that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06479811, a Phase 1 study of Kidney Cancers and Somatostatin Receptor Positive, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 68Ga-DOTATATE
- DRUG [203Pb]VMT-alpha-NET
- DRUG [212Pb]VMT-alpha-NET
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-08-19 |
| Est. Completion | 2032-01-01 |
| Phase | Phase 1 |
What NCT06479811 shows while recruiting
NCT06479811 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 6 conditions, with Kidney Cancers appearing as the primary indexed condition, and to 3 interventions - of which 68Ga-DOTATATE is the first listed.
NCT06479811 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06479811 about?
NCT06479811 is a clinical study titled "[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". 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 he...
What is the current status of trial NCT06479811?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2025-08-19. Estimated completion is 2032-01-01.
What conditions does trial NCT06479811 study?
This clinical trial studies the following conditions: Kidney Cancers, Somatostatin Receptor Positive, Gastrointestinal Neuroendocrine Tumors, Head and Neck Tumors, Small Cell Lung Cancers.
What interventions are being tested in trial NCT06479811?
The interventions under investigation include: 68Ga-DOTATATE (DRUG), [203Pb]VMT-alpha-NET (DRUG), [212Pb]VMT-alpha-NET (DRUG).
Who is sponsoring clinical trial NCT06479811?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06479811 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06479811's enrollment target sits among peer trials
120 480th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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