Non-Small Cell Lung CancerPhase 1NCT07140315

DK222 Study at Hopkins

A Phase 1 study testing [18F]DK222 radiotracer in people with Non-Small Cell Lung Cancer and Urothelial Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer, Urothelial Cancer
What is being tested?: [18F]DK222 radiotracer
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2027to 31 Jan 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Subjects must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
Subjects 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:

Show all 15Show fewer

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 surgically sterile or have been postmenopausal for ≥ 1 year.
WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.

Who cannot join

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.
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 ability of the patients to receive protocol therapy.
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehreen Nabi contact

14109296586

mnabi1@jh.edu

United States1 site, 1 recruiting

Johns Hopkins Hospital
Baltimore, Maryland, 21287
Mehreen Sr. Clinical Research Program Manager, MBBS, 410-502-0736, mnabi1@jh.edu
Seyed Ali Mosallaie, MD
Recruiting

Other trials in United States

About this study

Official title: 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

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
Being tested: [18F]DK222 radiotracer
Keywords: PD-L1, PD-1, PET, Imaging, MSCLC, UC, bladder cancer, lung cancer, radiotracer
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[18F]DK222 radiotracerDrug
[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 groups in NCT07140315
Study group	Role	What they receive
[18F]DK222 radiotracer	Experimental	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. Receives: Drug: [18F]DK222 radiotracer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Once up to 10 days post radiotracer injection

Secondary 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.
Measured: Once up to 10 days post radiotracer injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202731 Jan 2028

First posted24 Aug 2025
Study start31 Jan 2027 (estimated)
Primary completion31 Jan 2028 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07140315
Sponsor's protocol ID: J24119
Other IDs: IRB00462780
Status last verified: Sep 2026
First submitted: 18 Aug 2025
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07140315
Acronym / sponsor ID: J24119
Conditions: Non-Small Cell Lung Cancer, Urothelial Cancer
Keywords: PD-L1, PD-1, PET, Imaging, MSCLC, UC, bladder cancer, lung cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 6 participants (estimated)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Study start: 31 Jan 2027 (estimated)
Primary completion: 31 Jan 2028 (estimated)
Study completion: 31 Jan 2028 (estimated)
First posted: 24 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a first in human study to collect preliminary safety and toxicity data of [18F]DK222.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[18F]DK222 radiotracer	Experimental	Drug: [18F]DK222 radiotracerThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.
Subjects must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.

Key exclusion criteria (8 listed)

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.
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 ability of the patients to receive protocol therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[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.	Drug	[18F]DK222 radiotracer

Primary outcome

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

1 secondary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Mehreen Nabi contact

14109296586

mnabi1@jh.edu

Seyed Ali Mosallaie, MD principal investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehreen Nabi (14109296586, mnabi1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07140315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.