A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • LY4214835

    Drug

    Administered IV

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: LY4214835 (Cohorts 1 and 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs

Evaluation of the uptake of \[18F\]LY4214835 in tumor foci and other organs

Time frame
Baseline Through Day 3

Other outcomes

Sponsors and contacts

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