Recruiting
Phase 1

\[18F\]LY4214835

Sponsor:

Eli Lilly and Company

Code:

NCT07258836

Conditions

Neoplasms

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

LY4214835

Study Details

Brief 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.

Conditions

Neoplasms

Healthy

Study ID

NCT07258836

Start date

Dec 22, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

41 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4214835 (Cohorts 1 and 2)

LY4214835 administered intravenously (IV)

Interventions

LY4214835

Administered IV

Primary outcome measure

  • Number of Incidence of Adverse Events (AEs) [ Time Frame: Baseline Through Day 3 ]
  • Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose [ Time Frame: Baseline Through Day 3 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Ichor Research

Recruiting

Syracuse, New York, United States, 13210

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-06.