A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
Recruiting now · Phase 1
Conditions studied: Neoplasms, Healthy
In brief
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.
Key facts
- Study ID
- NCT07258836
- Run by
- Eli Lilly and Company
- People needed
- 41
- Starts
- 2025-12-22
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Ichor Research — Syracuse, New York, United States (enrolling)
- Invicro — New Haven, Connecticut, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital (MGH) — Charlestown, Massachusetts, United States
- BAMF Health Inc. — Grand Rapids, Michigan, United States
Full record on ClinicalTrials.gov
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