NCT07258836RecruitingPhase 1
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
Eli Lilly and Company6 sites in 1 country41 target enrollmentStarted: December 22, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 41
- Locations
- 6
- Primary Endpoint
- Number of Incidence of Adverse Events (AEs)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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)
Arms & Interventions
LY4214835 (Cohorts 1 and 2)
Experimental
LY4214835 administered intravenously (IV)
Intervention: LY4214835 (Drug)
Outcomes
Primary Outcomes
Number of Incidence of Adverse Events (AEs)
Time Frame: Baseline Through Day 3
Evaluation of AEs regardless of causality, will be reported in the Reported AEs module
Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose
Time Frame: Baseline Through Day 3
Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
Secondary Outcomes
- Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs(Baseline Through Day 3)
Investigators
Study Sites (6)
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