NeoplasmsPhase 1NCT07258836
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
A Phase 1 study testing LY4214835 in people with Neoplasms and Healthy, run by Eli Lilly and Company at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- LY4214835
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 Dec 2025to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
6 sites in 1 country
United States6 sites, 5 recruiting
- Not yet recruiting
Boston Medical Center
Boston, Massachusetts, 02118
- Not yet recruiting
Massachusetts General Hospital (MGH)
Charlestown, Massachusetts, 02129
- Not yet recruiting
BAMF Health Inc.
Grand Rapids, Michigan, 49503
- Completed
Invicro
New Haven, Connecticut, 06510
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Ichor Research
Syracuse, New York, 13210
About this study
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
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.
- Being tested
- LY4214835
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4214835Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4214835 (Cohorts 1 and 2) | Experimental | LY4214835 administered intravenously (IV) Receives: Drug: LY4214835 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Incidence of Adverse Events (AEs)
Evaluation of AEs regardless of causality, will be reported in the Reported AEs module
Measured: Baseline Through Day 3
Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose
Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
Measured: Baseline Through Day 3
Secondary outcomes (1)
Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs
Evaluation of the uptake of [18F]LY4214835 in tumor foci and other organs
Measured: Baseline Through Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start22 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258836
- Sponsor's protocol ID
- 27782
- Other IDs
- J6J-AV-AVCA
- Status last verified
- Nov 2026
- First submitted
- 21 Nov 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07258836
- Acronym / sponsor ID
- 27782
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY4214835 (Cohorts 1 and 2) | Experimental | Drug: LY4214835LY4214835 administered intravenously (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cohort 1
- Cohort 2
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4214835Administered IV | Drug | LY4214835 (Cohorts 1 and 2) |
Primary outcome
Number of Incidence of Adverse Events (AEs)
Time frame: 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
Time frame: Baseline Through Day 3
Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
1 secondary outcome
Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs
Time frame: Baseline Through Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4214835 in people with Neoplasms and Healthy, run by Eli Lilly and Company at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Incidence of Adverse Events (AEs) (time frame: Baseline Through Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.