DK222 Study at Hopkins (NCT07140315) | Clinical Trial Compass
RecruitingPhase 1
DK222 Study at Hopkins
United States6 participantsStarted 2026-07-01
Plain-language 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
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 record:
* White blood cells (WBC) ≥ 2000 /μL
* Absolute neutrophil count (ANC) ≥ 1500 /μL
* Platelets ≥ 100 x103 /μL
* Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
* Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatinine clearance greater than or equal to 60 ml/min (using the Cockcroft-Gault formula)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN
* Bilirubin ≤ 1.5 times ULN (Except patients with the Gilbert Syndrome, for whom a maximum of ≤ 3.0 mg/dL is acceptable)
* Women of childbearing potential (WOCBP) should have a negative serum pregnancy test within 24 hours prior to receiving the first administration \[18F\]DK222. Women wit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of [18F]DK222 as assessed by number of grade 3-5 adverse events
Timeframe: Once up to 10 days post radiotracer injection
Trial details
NCT IDNCT07140315
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins