Phase I Evaluation of 68GaGa-DWJ155 Imaging Agent for Adults with Advanced Breast and Non-Small Cell Lung Cancers

What this Trial Is About

Researchers are evaluating the imaging performance, safety, distribution in the body, and how the body processes the radioactive tracer 68GaGa-DWJ155 in adults aged 18 and older with advanced breast cancer and advanced non-small cell lung cancer adenocarcinoma. This phase I, open-label study focuses on two types of breast cancer hormone receptor positiveHER2 negative and HER2 positive, as well as advanced lung cancer, to better understand the tracers use in these conditions. Participants will receive a single dose of the radioactive imaging agent FKL480 68GaGa-DWJ155. The study includes an imaging characterization part and an expansion part, enrolling about 15-21 breast cancer patients and 9-15 lung cancer patients. The study observes the biodistribution, safety, pharmacokinetics, and radiation dosimetry of the agent after administration. During the study, participants undergo imaging and blood tests up to 240 minutes after dosing to measure tracer uptake in tumors and normal organs. Safety is monitored through adverse event tracking up to three days after dosing. Researchers will collect data on radiation exposure, urinary excretion, and blood radioactivity levels. The total participation time covers the dosing day and immediate follow-up assessments.

A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers