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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
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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)
About the study
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.
What is being tested
- LY4214835 (drug)
Sponsor: Eli Lilly and Company · Participants: 41 · Started: Dec 22, 2025
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07258836
Locations in the U.S.
| Massachusetts | Boston Medical Center, Boston (Not yet recruiting) Massachusetts General Hospital (MGH), Charlestown (Not yet recruiting) |
| Michigan | BAMF Health Inc., Grand Rapids (Not yet recruiting) |
| New York | Memorial Sloan Kettering Cancer Center, New York Ichor Research, Syracuse |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.