An Open-label, Single-center Clinical Trial of [18F]DK222 PET/CT for Imaging of Patients With Non-Small-Cell Lung Cancer (NSCLC) and Urothelial Cancer Who Are Eligible for Treatment With Anti-PD(L)-1

Plain English Summary

DK222 Study at Hopkins is a Phase 1 clinical trial sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins studying Non-Small Cell Lung Cancer, Urothelial Cancer. This trial tests a new imaging agent called [18F]DK222 to help visualize certain types of lung and bladder cancer. It is for patients with non-small cell lung cancer or urothelial cancer who are candidates for treatment with anti-PD(L)-1 therapy. Participants will receive an injection of the imaging agent and undergo a PET-CT scan. Currently, standard imaging techniques are used to monitor cancer, but this new agent aims to provide more specific information. The trial aims to enroll 6 participants.

Official 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

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have confirmed non-small cell lung cancer or urothelial cancer, and are eligible for anti-PD(L)-1 treatment. You must have a PD-L1 test result or enough tissue for testing, and have good general health with adequate organ function. You cannot join if you have previously received anti-PD-L1 or anti-PD-L2 therapy within a certain timeframe, have not recovered from side effects of prior cancer treatment, or have severe allergies to similar drugs. This trial is studying Non-Small Cell Lung Cancer, Urothelial Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures the safety of the new imaging agent by tracking any serious side effects, meaning it will help determine if the test is safe for patients. The specific primary outcome measures are: Safety of [18F]DK222 as assessed by number of grade 3-5 adverse events (Once up to 10 days post radiotracer injection). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial matters because it explores a new way to image specific cancers, potentially improving the selection of patients who can benefit from immunotherapy by better identifying PD-L1 expression. This research targets Non-Small Cell Lung Cancer, Urothelial Cancer, where improved treatment options are needed.

Investor Insight

This Phase 1 trial is an early step to assess a novel imaging agent for cancer, indicating potential for improved diagnostics in a market where precise patient selection for immunotherapy is crucial f Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this imaging test is appropriate for you and what the potential benefits and risks are. Participation involves receiving an injection of the imaging agent and undergoing a PET-CT scan. You will need to have specific lab tests and potentially provide tissue samples before the scan. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 6 participants

Interventions

• DRUG: [18F]DK222 radiotracer — \[18F\]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.

Primary Outcomes

• Safety of [18F]DK222 as assessed by number of grade 3-5 adverse events (Once up to 10 days post radiotracer injection)

Secondary Outcomes

• Tolerability of [18F]DK222 as assessed by number of grade 3-5 adverse events (Once up to 10 days post radiotracer injection)

Full Eligibility Criteria

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 with non-childbearing potential may be included if either surgically sterile or have been postmenopausal for ≥ 1 year.
* WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.

Exclusion Criteria:

* Prior treatment, in either de novo disease or during this recurrence, with an anti-PD-L1 or anti-PD-L2 antibody. A minimum of 4 month washout period is required for patients treated with anti-PD-L1 or anti-PD-L2 therapy. Patients with disease that was previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, but now have a new recurrence, would be eligible.
* Subjects who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1 or better from the adverse events due to previous cancer therapy.
* Treatment with corticosteroids in an increasing dosage in the 7 days prior to the first administration of anti-PD1. (A stable or decreasing dosage of ≤ 10 mg dexamethasone or equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
* A severe hypersensitivity reaction to prior treatment with a monoclonal antibody, or known hypersensitivity to study drugs components.
* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patients to receive protocol therapy.
* Women of childbearing potential with a positive serum or urine pregnancy test (minimum sensitivity 10 IU/L or equivalent units of HCG) within 24 hours prior to the start of imaging.
* Breastfeeding women.
* Inability to comply with other requirements of the protocol.

Trial Locations

• Johns Hopkins Hospital, Baltimore, Maryland, United States

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Urothelial Cancer
• Bladder Cancer
• Lung Cancer
• Immunotherapy
• PD-1 Inhibitors
• PD-L1 Inhibitors
• Cancer Imaging
• Radiopharmaceuticals
• Oncology

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