Clinical Trials in the USA / NCT07258836
Recruiting
Phase 1
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
NCT07258836 · tracked via the Priya Life Science USA tracker
Condition(s) studied
NeoplasmsHealthy
Investigational drug(s) / intervention(s)
LY4214835
LY4214835: Administered IV
Study 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.
Eligibility
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)
Primary outcome measure(s)
- Number of Incidence of Adverse Events (AEs) — Baseline Through Day 3
Evaluation of AEs regardless of causality, will be reported in the Reported AEs module - Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose — Baseline Through Day 3
Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Invicro | New Haven | Connecticut | Completed |
| Boston Medical Center | Boston | Massachusetts | Not Yet Recruiting |
| Massachusetts General Hospital (MGH) | Charlestown | Massachusetts | Not Yet Recruiting |
| BAMF Health Inc. | Grand Rapids | Michigan | Not Yet Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Ichor Research | Syracuse | New York | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07258836 on ClinicalTrials.gov ↗ ← All trials in the USA