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

Yusuf Menda

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Neuroendocrine Tumor Grade 2

Neuroendocrine Tumor Grade 1

Treatments

Device: SPECT/CT

Drug: [203Pb]VMT-α-NET

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT05111509

202006288

5R01CA243014 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The goal of this work is to use [203Pb]VMT-α-NET as the imaging agent to create a specialized patient treatment plan using [212Pb]VMT-α-NET as a first-in-human therapy for treatment resistant or refractory neuroendocrine tumors of the foregut or midgut. The first step is to test the imaging agent [203Pb]VMT-α-NET. This requires a very small dose of the drug (microdose) which is then measured by a series of images (like CT scans) over 4 days. Blood samples are also drawn that that time. It is hoped the imaging will identify the tumors so that a therapy using [212Pb]VMT-α-NET can be created.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 an FDA approved PET agent 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

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.
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.
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.