A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
NCT ID: NCT07258836
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
41 participants
INTERVENTIONAL
2025-12-31
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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LY4214835 (Cohorts 1 and 2)
LY4214835 administered intravenously (IV)
LY4214835
Administered IV
Interventions
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LY4214835
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Invicro
New Haven, Connecticut, United States
Boston Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts, United States
BAMF Health Inc.
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Other Identifiers
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J6J-AV-AVCA
Identifier Type: OTHER
Identifier Source: secondary_id
27782
Identifier Type: -
Identifier Source: org_study_id