NCT06479811View on ClinicalTrials.gov

[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

PHASE1RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 19, 2025

Primary Completion Date

January 1, 2029

Study Completion Date

January 1, 2032

Conditions
Head and Neck TumorsKidney CancersSmall Cell Lung CancersPheochromocytoma/ParagangliomasGastrointestinal Neuroendocrine TumorsSomatostatin Receptor Positive
Interventions
DRUG

68Ga-DOTATATE

68Ga-DOTATATE PET/CT whole-body scanning will be done at at different intervals to monitor disease.

DRUG

[203Pb]VMT-alpha-NET

\[203Pb\]VMT-alpha-NET will be given IV 7 days prior to \[212Pb\]VMT-alpha-NET.

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 dose expansion. 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