[18F]DK222 for Lung and Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug called [18F]DK222, an experimental treatment, to assess its safety and how it travels and acts inside the body. [18F]DK222 is designed to attach to a specific protein that helps lung and bladder cancers evade the immune system. The trial uses a PET-CT scan to determine where the drug accumulates after injection. It suits individuals diagnosed with non-small cell lung cancer (NSCLC) or urothelial carcinoma (UC) who have not received certain immune therapies and are eligible for anti-PD(L)-1 therapy. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but there is a 4-month period without anti-PD-L1 or anti-PD-L2 therapy required. If you're on corticosteroids, the dosage should be stable or decreasing and not exceed 10 mg of dexamethasone or equivalent.
Is there any evidence suggesting that [18F]DK222 is likely to be safe for humans?
Research shows that \[18F\]DK222 is under investigation for its safety and effectiveness in detecting cancer. This marks its first test in humans. As a Phase 1 trial, the primary aim is to gather preliminary data on the treatment's safety and tolerability. With no prior human data for \[18F\]DK222, its safety profile remains not fully understood. However, Phase 1 trials are meticulously designed to monitor potential side effects. Participants should understand that the main objective is to learn about safety and the treatment's behavior in the body.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about [18F]DK222 because it offers a new way to detect lung and bladder cancers more precisely. Unlike standard imaging techniques that might not clearly show where cancer cells are located, [18F]DK222 is a radiotracer that accumulates in cancerous areas, making them light up during a PET-CT scan. This approach could improve diagnostic accuracy, providing doctors with clearer images and potentially leading to better treatment decisions. Additionally, the use of [18F]DK222 might help in identifying cancer spread earlier than current methods.
What evidence suggests that [18F]DK222 might be an effective treatment for lung and bladder cancer?
Research has shown that \[18F\]DK222 is a special substance that binds to PD-L1, a protein that helps cancer evade the immune system. In studies with mice possessing human-like immune systems, \[18F\]DK222 successfully highlighted cancer areas by attaching to PD-L1, making tumors easier to detect. This substance has also demonstrated how different treatments affect tumors. Although this trial marks the first time \[18F\]DK222 is being tested in humans, these early results suggest it could aid in diagnosing and monitoring lung and bladder cancers.12345
Who Is on the Research Team?
Seyed Ali Mosallaie, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Are You a Good Fit for This Trial?
The DK222 Study at Hopkins is for individuals with non-small cell lung cancer, lung cancer, or bladder cancer. It's a first-in-human study to test the safety of a new drug called [18F]DK222 that targets PD-L1 protein.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the [18F]DK222 radiotracer and undergo a PET-CT scan to evaluate safety and diagnostic performance
Follow-up
Participants are monitored for safety and tolerability of [18F]DK222, with adverse events assessed up to 10 days post-injection
What Are the Treatments Tested in This Trial?
Interventions
- [18F]DK222
Trial Overview
[18F]DK222 radiotracer is being tested in this Phase 1 trial. The focus is on assessing its safety profile, distribution and retention in the body, and radiation emission levels.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]DK222 radiotracer in NSCLC and UC participants. Participants will undergo a PET-CT scan after \[18F\]DK222 is injected into the participant's vein an intravenous line. This is the imaging procedure to assess where \[18F\]DK222 has accumulated in the body.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Citations
NCT07140315 | DK222 Study at Hopkins
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of [18F]DK222 radiotracer in NSCLC and UC participants.
Non-invasive PD-L1 quantification using [18F]DK222-PET ...
Moreover, [18F]DK222-PET was able to differentiate the impact of different therapies on tumors. Keywords: PET, Immune Checkpoint Inhibitors, ...
NCT07140315
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 ...
[18F]DK222 for Lung and Bladder Cancer
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]DK222 radiotracer in NSCLC and UC participants ...
5.
researchgate.net
researchgate.net/publication/374460519_Non-invasive_PD-L1_quantification_using_18_FDK222-PET_imaging_in_cancer_immunotherapyNon-invasive PD-L1 quantification using [ 18 F]DK222-PET ...
[ ¹⁸ F]DK222, a peptide-based PD-L1 imaging agent, was investigated in this study using humanized mouse models to explore the relationship ...
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