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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yusuf Menda
• Collaborators: Holden Comprehensive Cancer Center; National Cancer Institute (NCI); Viewpoint Molecular Targeting

Criteria

Inclusion Criteria:

• Ability to understand and willingness to provide informed consent

• Stated willingness to comply with all study procedures and availability for duration of study

• Aged ≥ 18 years at the time of study drug administration

• 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

• At least 1 somatostatin receptor positive tumor site as demonstrated by PET/CT study utilizing [68Ga]DOTATOC or [68Ga]DOTATATE within 12 months of consent

• ≥1 evaluable site of disease measuring ≥ 2.0 cm in any dimension on CT or MRI

• Adequate performance status (ECOG of 0 or 1; or KPS of ≥70).

• 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.

Exclusion Criteria:

• Women who are pregnant or breast feeding. A pregnancy test will be administered to women of child-bearing potential (per institutional policies) at screening. Women must agree to pregnancy tests prior to each administration of a radionuclidic agent for this study.

• Females or males of reproductive potential who decline to use effective contraception through the study (22 days equaling 10 half-lives).

• Lactating women 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.

• Therapeutic investigational drug within 4 weeks of C1D1

• Patients for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk.

• Subject's weight exceeds the limit of the imaging system.

• Long-acting somatostatin analogue treatment ≤ 20 days of C1D1

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to [90Y]DOTA-tyr3-Octreotide, Octreoscan®, or [68Ga]Octreotide.