Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07258836

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Neoplasms Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Invicro, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LY4214835

Drug

Administered IV

Primary outcomes

  1. 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

  2. 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

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

    Time frame: Baseline Through Day 3

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

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.