Phase 0 Study of Two Zirconium-89 Labeled Vartumabs for PETCT Imaging in Adults With Solid Tumors

What this Trial Is About

Researchers are evaluating two antibody fragments that target oncofetal chondroitin sulfate CS, a tumor-specific marker found in most cancers but not in healthy tissues. This Phase 0 PETCT molecular imaging study aims to investigate how these radiolabeled antibody fragments distribute, accumulate in tumors, and are cleared from the body in patients with solid tumors. The study focuses on biodistribution, pharmacokinetics, pharmacodynamics, and safety in a diverse group of cancer patients. Participants will receive a single intravenous microdose of one of two radiolabeled antibody fragments named 89Zr-F8scFv or 89Zr-C9scFv. Initially, the first three patients in each group receive a set dose followed by three whole-body PETCT scans on days 1, 2, and 4 to determine the best scanning schedule and radiation dose. Subsequent patients receive a dose between 15 to 30 MBq followed by one PETCT scan on the optimal day. Each participant has a follow-up visit about 28 days after receiving the study drug. During the study, participants undergo whole-body PETCT scans to track the antibody fragments, and researchers monitor tumor-specific uptake and overall safety through adverse event reporting up to 56 days. The study includes assessments of liver and kidney function, vital signs, and ECG. Researchers plan to analyze pharmacokinetics and tumor targeting across multiple cancer types, with total participation spanning from dosing to about one month of follow-up.

PET-imaging of Two Vartumabs in Patients With Solid Tumors