Clinical Trial · NCT05111509

A First-in-human Clinical Trial to Evaluate an Alpha-radiation Imaging Agent

Overview

This is a first in man study to determine if \[203Pb\]VMT-α-NET identifies neuroendocrine tumors with SPECT/CT. This is the first step to testing \[212Pb\]-based alpha radiation therapy in neuroendocrine therapy.

Sponsor

University of Iowa

Phase

Early Phase 1

Contacts

Yusuf Menda, M.D. (STUDY_CHAIR)

ClinicalTrials.gov

NCT05111509

Drug / Compound

VMT-α-NET

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: PSC

Linker: PEG2

Eligibility

Inclusion

Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).
≥1 evaluable site of disease measuring ≥ 2.0 cm in any dimension on CT or MRI
Not experiencing an uncontrolled intercurrent illness such as: infection requiring inpatient admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing an FDA approved PET agent within 12 months of consent
Stated willingness to comply with all study procedures and availability for duration of study
Pathologically confirmed (histology or cytology) well-differentiated neuroendocrine tumor (WHO Grade 1 or 2) with primary location known or believed to be midgut or foregut

Exclusion

Therapeutic investigational drug within 4 weeks of C1D1
Subject's weight exceeds the limit of the imaging system.
Individuals of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).
Lactating individuals who decline to withhold breastfeeding their child. As the effects of \[203Pb\]VMT-α-NET on the infant are unknown and relatively long half-life, women may not resume breast feeding for the current child.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[90Y\]DOTA-tyr3-Octreotide, Octreoscan®, or \[68Ga\]Octreotide.
Long-acting somatostatin analogue treatment ≤ 20 days of C1D1
Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.
Individuals who are pregnant or breast feeding. A pregnancy test will be administered to individuals of child-bearing potential (per institutional policies) at screening. Individuals must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.