Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 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

NCT ID: NCT07258836Sponsor: Eli Lilly and CompanyLast updated: 2026-04-17

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

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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)

Study locations (6)

Invicro

New Haven, Connecticut, 06510

Recruiting

Boston Medical Center

Boston, Massachusetts, 02118

Not Yet Recruiting

Massachusetts General Hospital (MGH)

Charlestown, Massachusetts, 02129

Not Yet Recruiting

BAMF Health Inc.

Grand Rapids, Michigan, 49503

Not Yet Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Not Yet Recruiting

Ichor Research

Syracuse, New York, 13210

Not Yet Recruiting