A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4214835.
- Who it may be relevant to
- Registry conditions: Neoplasms, Healthy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug LY4214835
Administered IV
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs [Time frame: Baseline Through Day 3]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 6 centers
- Invicro — New Haven
- Boston Medical Center — Boston
- Massachusetts General Hospital (MGH) — Charlestown
- BAMF Health Inc. — Grand Rapids
- Memorial Sloan Kettering Cancer Center — New York
- Ichor Research — Syracuse
Identifiers
NCT: NCT07258836 · 27782 · J6J-AV-AVCA