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New treatment option for Non-Small Cell Lung Cancer
Official title DK222 Study at Hopkins
ClinicalTrials.gov ID: NCT07140315
What this study is testing
What is [18F]DK222 radiotracer?
[18F]DK222 radiotracer is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must sign informed consent prior to inclusion in this trial.
- people must be ≥18 years of age and competent to give informed consent.
- people 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...
- people must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
You likely can't join if
- 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...
- people who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1 or better from the adverse events due to...
- 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...
- 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...
- Women of childbearing potential with a positive serum or urine pregnancy test (minimum sensitivity 10 IU/L or equivalent units of HCG) within 24...
See the full eligibility criteria
- people must sign informed consent prior to inclusion in this trial.
- people must be ≥18 years of age and competent to give informed consent.
- people 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.
- people must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- people 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...
- WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.
- 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...
- people 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.