DK222 Study at Hopkins

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT07140315
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: [18F]DK222 radiotracer
    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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Mehreen Sr. Clinical Research Program Manager, MBBS
[email protected]
410-502-0736
Seyed Ali Mosallaie, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Lung cancerBladder cancer
By specialty
OncologyLung oncologyLung diseaseUrology
By research site
Johns Hopkins Hospital· Baltimore, MD

Related Studies