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

Launched by YUSUF MENDA · Oct 30, 2021

Keywords

ClinConnect Summary

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 c...

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Eligibility 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 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.