An Open-label, Single-center Clinical Trial of [18F]DK222 PET/CT for Imaging of Patients With Non-Small-Cell Lung Cancer (NSCLC) and Urothelial Cancer Who Are Eligible for Treatment With Anti-PD(L)-1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
This Phase 1 clinical trial will test a new drug called \[18F\]DK222 in people with cancer. The goal is to see if the drug is safe, how it spreads through the body, how long it stays in the body, and how much radiation it gives off. \[18F\]DK222 is designed to attach strongly and specifically to a protein called PD-L1, which helps cancer hide from the immune system. This is a first in human study to collect preliminary safety and toxicity data of \[18F\]DK222.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must sign informed consent prior to inclusion in this trial. * Subjects must be ≥18 years of age and competent to give informed consent. * Subjects must be diagnosed with histologically confirmed NSCLC or UC and eligible for anti-PD(L)-1 therapy. * PD-L1 immunohistochemistry result using a Clinical Laboratory Improvement Amendments (CLIA) assay must be available or if not available then sufficient tissue must be available to perform PD-L1 testing. * Subjects must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status. * Subject…
Interventions
- Drug[18F]DK222 radiotracer
\[18F\]DK222 is an investigational radiotracer used detect non-small cell lung cancer (NSCLC) or Urothelial Cancer (UC) tissue in the body when used with positron emission tomography/computed tomography. Participants will undergo a PET-CT scan after \[18F\]DK222 is injected into the participant's vein an intravenous line.
Location
- Johns Hopkins HospitalBaltimore, Maryland