NCT07258836PHASE1RecruitingAccepts Healthy Volunteers
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
Eli Lilly and Company
Start Date
12/22/2025
Completion Date
1/1/2027
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 Criteria
Age Range: 18 years to No maximum
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)
Interventions
DRUG
LY4214835
Conditions
NeoplasmsHealthy
Locations
Invicro
New Haven, Connecticut 06510
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts 02129
United States
BAMF Health Inc.
Grand Rapids, Michigan 49503
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Ichor Research
Syracuse, New York 13210
United States