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Recruiting Phase 1 NCT07258836

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

Phase 1 – testing safety in a small group of people
Conditions: Neoplasms Healthy

Sponsor: Eli Lilly and Company

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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.
Who can participate
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)
Interventions
LY4214835
DRUG
Locations 6
United States (6)
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
Invicro
New Haven , Connecticut
Memorial Sloan Kettering Cancer Center
New York , New York
NOT_YET_RECRUITING
Ichor Research
Syracuse , New York
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.12.2025
Completion date
01.01.2027
Registry ID
NCT07258836
Source
clinicaltrials.gov
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.