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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
\[18F\]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.
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGSafety of [18F]DK222 as assessed by number of grade 3-5 adverse events
Any grade 3-5 toxicity attributed to \[¹⁸F\]DK222 administration will be considered as not meeting the safety endpoint. All adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Once up to 10 days post radiotracer injection
Tolerability of [18F]DK222 as assessed by number of grade 3-5 adverse events
. Any grade 3-5 toxicity attributed to \[¹⁸F\]DK222 administration will be considered as not meeting the tolerability endpoint. All adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Once up to 10 days post radiotracer injection
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