NCT07140315

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer
• Urothelial Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-08-24
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study