RecruitingPhase 1NCT07258836

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

A Phase 1, Open-Label Study to Evaluate the Safety, Biodistribution, Imaging Characteristics, and Radiation Dosimetry of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer

Sponsor

Eli Lilly and Company

Enrollment

41 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Neoplasms Healthy

Summary

The purpose of the study is to check how safe and well-tolerated \[18F\]LY4214835 injection is in healthy participants and participants with cancer. The study drug will be administered intravenously (IV) (into a vein). Participation in the study will last approximately 35 days.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria5

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)

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