RecruitingPhase 1

DK222 Study at Hopkins

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [18F]DK222 in people for the first time to learn about its safety, movement through the body, and radiation levels. The drug attaches to PD-L1, a protein that helps cancer hide from the immune system. It is for adults with non-small cell lung cancer or urothelial cancer, which affects the lining of the urinary tract.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, able to understand the study, and sign a consent form.
  • Have non-small cell lung cancer or urothelial cancer confirmed by a tissue test, and qualify for anti-PD(L)-1 treatment, which helps the immune system fight cancer.
  • Have a PD-L1 test result from a certified lab, or enough tumor tissue for this test.
  • Have an activity score of 0 to 2, meaning you can care for yourself and are out of bed for at least half the day.
  • Have blood counts, kidney tests, and liver tests that meet study limits within 28 days before joining, unless your doctor decides any differences are not medically important.
  • If you can become pregnant, have a negative blood pregnancy test within 24 hours before the first dose.
  • If you cannot become pregnant, have had surgery that prevents pregnancy or have been past menopause for at least 1 year.
  • If you can become pregnant, or are a man sexually active with someone who can, agree to use suitable birth control.

Who can't join

  • Have had anti-PD-L1 or anti-PD-L2 treatment for the current cancer episode. The rules require at least 4 months off these drugs; people with a new cancer recurrence after earlier immune treatment may qualify.
  • Still have side effects from earlier cancer treatment that are more than mild.
  • Have increased your steroid dose in the 7 days before the first anti-PD-1 treatment. Stable or lower doses up to 10 mg of dexamethasone, or an equal dose of another steroid, are allowed. Some inhaled, skin, or hormone-replacement steroids are also allowed if you have no active autoimmune disease.
  • Have had a severe allergic reaction to a monoclonal antibody, a type of lab-made protein drug, or have a known allergy to any study drug ingredient.
  • Have a serious or uncontrolled illness or active infection that the study doctor thinks would make participation unsafe or prevent treatment.
  • Have a positive pregnancy test within 24 hours before imaging.
  • Are breastfeeding.
  • Cannot follow the study's other requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD