PET imaging with [18F]LY4214835 in adults with cancer and healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial gives a single intravenous dose of the PET tracer [18F]LY4214835 to two groups: adults with confirmed cancer and imageable tumors, and overtly healthy volunteers. Participants will undergo PET imaging after the injection and be monitored with clinical exams, labs, and ECGs for safety and tolerability over roughly 35 days. The cancer cohort includes people who are treatment‑naïve or who have progressed on standard therapies and requires at least one tumor ≥15 mm for imaging. Exclusion criteria include pregnancy, breastfeeding, and certain cardiac risk factors.

Why it matters

Who can join: the full rules

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)

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Ichor Research
  Syracuse, New York, United States Recruiting
• Invicro
  New Haven, Connecticut, United States Completed
• Boston Medical Center
  Boston, Massachusetts, United States Not yet recruiting
• Massachusetts General Hospital (MGH)
  Charlestown, Massachusetts, United States Not yet recruiting
• BAMF Health Inc.
  Grand Rapids, Michigan, United States Not yet recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.