An Open-label, Single-center Clinical Trial of [18F]DK222 PET/CT for Imaging of Patients With Non-Small-Cell Lung Cancer and Urothelial Cancer Eligible for Anti-PD(L)-1 Treatment

What this Trial Is About

Researchers are evaluating a new drug called [18F]DK222 in a Phase 1 clinical trial involving people with non-small cell lung cancer (NSCLC) or urothelial cancer (UC). The study aims to determine the safety of [18F]DK222, how it moves through the body, how long it remains, and the amount of radiation it emits. This is the first time [18F]DK222 is being tested in humans to gather preliminary safety and toxicity information. [18F]DK222 is designed to attach specifically to a protein called PD-L1, which helps cancer evade the immune system. Participants will receive an injection of the investigational [18F]DK222 radiotracer through an intravenous line. After the injection, they will undergo a PET-CT scan to visualize where the radiotracer accumulates in the body. The study is open-label and involves a single treatment arm focused on assessing the safety and diagnostic performance of [18F]DK222 in people with NSCLC and UC who are eligible for anti-PD(L)-1 therapy. During the study, researchers will monitor participants for any adverse events up to 10 days after the radiotracer injection to assess safety and tolerability. The main outcome is the number of severe adverse events (grade 3 to 5). Participants will have their organ function and overall health evaluated before joining, and women of childbearing potential will have pregnancy tests. The entire participation timeline includes screening, injection, imaging, and follow-up safety assessments.

DK222 Study at Hopkins