NCT06427798View on ClinicalTrials.gov

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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 7, 2025

Primary Completion Date

July 1, 2029

Study Completion Date

July 1, 2039

Conditions
Somatostatin Receptor PositiveGastrointestinal Neuroendocrine TumorsPheochromocytomaParagangliomas
Interventions
DRUG

68Ga-DOTATATE

68Ga-DOTATATE PET/CT whole-body scanning will be done at target dose of 5 mCi. The whole-body PET/CT scan will be started approximately 60 minutes after the tracer injection and will take up to 2 hours.

DRUG

[203Pb]VMT-alpha-NET

\[203Pb\]VMT-alpha-NET (6 mCi) will be given IV at 7 days prior.

DRUG

[212Pb]VMT-alpha-NET

\[212Pb\]VMT-alpha-NET will be given IV on Day 1 of every cycle for 4 cycles total at escalating doses in Phase I and at MTD during Phase II. One cycle is 8 weeks.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH