Clinical trial · Interventional
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
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
NCT07258836CI-TRIAL-00120854recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY4214835 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LY4214835 (Cohorts 1 and 2)
- description
- LY4214835 administered intravenously (IV)
- interventionNames
- Drug: LY4214835
Primary outcomes (2)
- measure
- Number of Incidence of Adverse Events (AEs)
- timeFrame
- Baseline Through Day 3
- description
- Evaluation of AEs regardless of causality, will be reported in the Reported AEs module
- measure
- Number of Radiation Absorbed Dose Estimates in Body Organs to Obtain Whole-body Effective Dose
- timeFrame
- Baseline Through Day 3
- description
- Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.