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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy; Neoplasms

Treatments: Drug: LY4214835

Study type: Interventional

Funder types: Industry

Identifiers

NCT07258836

J6J-AV-AVCA (Other Identifier)

27782

Details and patient eligibility

About

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

LY4214835 (Cohorts 1 and 2)

Experimental group

Description:

LY4214835 administered intravenously (IV)

Treatment:

Drug: LY4214835