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A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
RECRUITINGPhase 1Sponsored by Eli Lilly and Company
Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2025-12-22
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →
NCT07258836
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
Age: 18 Years+Healthy volunteers accepted
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)
Conditions3
CancerHealthyNeoplasms
Locations6 sites
Invicro
New Haven, Connecticut, 06510
Boston Medical Center
Boston, Massachusetts, 02118
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts, 02129
BAMF Health Inc.
Grand Rapids, Michigan, 49503
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhasePhase 1
SponsorEli Lilly and Company
Started2025-12-22
Est. completion2027-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →
NCT07258836