DK222 Study at Hopkins
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
[18F]DK222 radiotracer
Drug\[18F\]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.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: [18F]DK222 radiotracerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of [18F]DK222 as assessed by number of grade 3-5 adverse events
Any grade 3-5 toxicity attributed to \[¹⁸F\]DK222 administration will be considered as not meeting the safety endpoint. All adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Once up to 10 days post radiotracer injectionSecondary outcomes
1
Tolerability of [18F]DK222 as assessed by number of grade 3-5 adverse events
. Any grade 3-5 toxicity attributed to \[¹⁸F\]DK222 administration will be considered as not meeting the tolerability endpoint. All adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
Once up to 10 days post radiotracer injectionSponsors and contacts
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Source ClinicalTrials.gov