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

Purpose

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.

Conditions

  • Neoplasms
  • Healthy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY4214835 (Cohorts 1 and 2) 		LY4214835 administered intravenously (IV)
  • Drug: LY4214835
    Administered IV

Recruiting Locations

Invicro
New Haven, Connecticut 06510

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com