OncoMatch/Clinical Trials/NCT06427798
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy
Is NCT06427798 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including 68Ga-DOTATATE and [203Pb]VMT-alpha-NET for somatostatin receptor positive.
Treatment: 68Ga-DOTATATE · [203Pb]VMT-alpha-NET · [212Pb]VMT-alpha-NET — Background: Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR. Objective: To test a drug (\[212Pb\]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells. Eligibility: Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery. Design: Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function. \[212Pb\]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may need to stay in the hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of 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 for 10 years....
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic radioligand therapy
Have received at least 1 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 (<= 5x ULN if due to benign process such as Gilbert syndrome); AST <= 2.5x ULN; ALT <= 2.5x ULN
Cardiac function
QTc > 450 ms on EKG at screening excluded (Framingham correction for QTc will be used)
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 excluded (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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