Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07140315

DK222 Study at Hopkins

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-04-02

6

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

DK222 Study at Hopkins

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must provide informed consent before joining the trial.
  • Participants must be 18 years or older and able to give informed consent.
  • Participants must have histologically confirmed NSCLC or UC and be eligible for anti-PD(L)-1 therapy.
  • PD-L1 test results must be available or sufficient tissue must be available for PD-L1 testing.
  • Participants must have an ECOG Performance Status score between 0 and 2.
  • Participants must have adequate organ function based on recent lab tests or physician assessment, including WBC ≥ 2000/µL, ANC ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9 g/dL, serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 ml/min, AST and ALT ≤ 3 times ULN, and bilirubin ≤ 1.5 times ULN (up to 3.0 mg/dL for Gilbert Syndrome).
  • Women of childbearing potential must have a negative pregnancy test within 24 hours before receiving [18F]DK222.
  • Women who are not of childbearing potential must be surgically sterile or postmenopausal for at least 1 year.
  • Sexually active women of childbearing potential and men must agree to use contraception.
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-PD-L1 or anti-PD-L2 antibody within 4 months before the study.
  • Participants who have not recovered to Grade 1 or better from adverse events caused by previous cancer treatments.
  • Treatment with increasing doses of corticosteroids within 7 days before anti-PD1 administration (stable or decreasing doses ≤ 10 mg dexamethasone or equivalent allowed).
  • History of severe allergic reaction to monoclonal antibodies or known allergy to study drug components.
  • Serious or uncontrolled medical disorders or active infections that increase risk or interfere with study participation.
  • Women of childbearing potential with a positive pregnancy test within 24 hours before imaging.
  • Breastfeeding women.
  • Inability to comply with study requirements.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

M

Mehreen Nabi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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