[18F]DK222 for Lung and Bladder Cancer

Overseen By Mehreen Nabi

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must be taking: Anti-PD(L)-1 therapy

Must not be taking: Corticosteroids, Monoclonal antibodies

Disqualifiers: Uncontrolled disorders, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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

I am 18 years or older and can legally consent.

I can care for myself and am up and about more than 50% of my waking hours.

Subjects must sign informed consent prior to inclusion in this trial

Exclusion Criteria

Inability to comply with other requirements of the protocol

Breastfeeding women

I haven't had PD-L1 or PD-L2 antibody treatment in the last 4 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the [18F]DK222 radiotracer and undergo a PET-CT scan to evaluate safety and diagnostic performance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability of [18F]DK222, with adverse events assessed up to 10 days post-injection

10 days

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?

Group I: [18F]DK222 radiotracer Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07140315

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10551964/

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, ...

3. theranostictrials.org theranostictrials.org/studies/cl74bp9il0261ajjfrm1lc6fe/study/NCT07140315

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 ...

4. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-9-2025-aee6c

[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_immunotherapy

Non-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 ...