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
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.
Arms & interventions
- DrugLY4214835
Administered IV
Outcome measures
Primary
Number of Incidence of Adverse Events (AEs)
Evaluation of AEs regardless of causality, will be reported in the Reported AEs module
Time frame: Baseline Through Day 3
Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose
Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
Time frame: Baseline Through Day 3
Secondary
Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs
Time frame: Baseline Through Day 3
Eligibility criteria
Study locations (6)
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
Ichor Research
Syracuse, New York, 13210