A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer

This study is looking at how safe and well-tolerated a drug called [18F]LY4214835 is when given intravenously (into a vein). It's being tested in both healthy volunteers and people with cancer. The researchers want to see if there are any side effects and how the body handles the drug, specifically how much radiation is absorbed by different organs. This study is for adults aged 18 and older. If you have cancer, you might be able to join if your cancer has been confirmed and you haven't had systemic cancer treatment yet, or if your current treatment isn't working. You would also need to have at least one tumor that is 15 millimeters (mm) or larger. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 41 participants, including both healthy volunteers and individuals with cancer.
What's involved
Your participation in the study will last approximately 35 days. The study drug, [18F]LY4214835, will be given intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for adverse events and radiation absorbed dose estimates from baseline through Day 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07258836

A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer

Recruiting
PHASE1Ages 18+InterventionalBasic science
Eli Lilly and Company
~41 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:LY4214835

At a glance

Recruiting sites
2 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Incidence of Adverse Events (AEs)
Measured over Baseline Through Day 3
+1 more outcome measured
Neoplasms
Healthy
6 sites across 4 states
Massachusetts2
New York2
Connecticut1
Michigan1
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cohort 1
Have a radiologically, cytologically, or histologically confirmed diagnosis of cancer
Are treatment-naïve to a systemic cancer therapy, OR have a documented disease progression on standard-of-care treatment (for example, failure of chemotherapy, targeted therapy or immunotherapy)
Have at least 1 imageable tumor that is 15 millimeter (mm) or larger in the longest diameter
Cohort 2
Are overtly healthy at the Screening Visit and upon reporting to the clinic for the positron emission tomography (PET) Imaging Visit, as determined by medical evaluation including updated medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG)

Exclusion

Are pregnant or intend to become pregnant during their participation in the study
Are breastfeeding or intending to breastfeed during their participation in the study
Have a history of risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome)
Are actively receiving cancer therapy or are in between cycles of treatment
Have a marked baseline prolongation of QT/corrected QT interval (QTc) interval (for example, repeated demonstration of a QTc interval greater than (\>) 450 millisecond (ms)
  • Number of Incidence of Adverse Events (AEs)Baseline Through Day 3

    Evaluation of AEs regardless of causality, will be reported in the Reported AEs module

  • Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective DoseBaseline Through Day 3

    Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose