PET imaging with [18F]LY4214835 in adults with cancer and healthy volunteers
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
This research will test a single IV injection of [18F]LY4214835 in adults with cancer and in healthy volunteers to see if it is safe and well tolerated.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 6 sites (New Haven, Connecticut and 5 other locations) |
| Trial ID | NCT07258836 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a confirmed cancer diagnosis who are treatment‑naïve or have progressed on standard therapy and have at least one imageable tumor ≥15 mm, or healthy adults who meet screening criteria, are the intended participants.
Not a fit: People who are pregnant or breastfeeding, those with cardiac risk factors for Torsades de Pointes, or individuals without sufficiently large imageable tumors are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If safe and well tolerated, this tracer could give doctors a new PET imaging tool to better visualize tumors and aid diagnosis or treatment planning.
How similar studies have performed: Other 18F-labeled PET tracers have been successfully used for tumor imaging, but this specific compound is early-stage and has limited human data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut and 5 other locations
- Invicro — New Haven, Connecticut, United States (Recruiting)
- 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)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Not_yet_recruiting)
- Ichor Research — Syracuse, New York, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.