DK222 Study at Hopkins
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,
| Condition(s) | Non-Small Cell Lung Cancer, Urothelial Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. * Subjects must have adequate organ function as defined by the following laboratory values (determined within 28 days prior to randomization/registration) or as deemed not clinically significant by physician on |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Locations | Baltimore, Maryland, United States |
| Start date | 2026-07-01 |
| NCT ID | NCT07140315 |
| Official listing | https://clinicaltrials.gov/study/NCT07140315 |