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LY4214835

Phase 1

Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Apr 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07258836A Study of [18F]LY4214835 in Healthy Volunteers and Participants With CancerPHASE1 RECRUITING 41Dec 22, 2025Jan 1, 2027Apr 17, 20266 United States
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Study Endpoints
Primary Endpoints
Number of Incidence of Adverse Events (AEs)
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
Baseline Through Day 3

Determination of the radiation dosimetry absorbed dose in body organs and whole-body effective dose

Secondary Endpoints
Number of Uptake of [18F]LY4214835 in Tumor Foci and Other Organs
Baseline Through Day 3
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4214835 (Cohorts 1 and 2)EXPERIMENTALLY4214835 administered intravenously (IV)
Interventions
NameTypeDescription
LY4214835DRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites6

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 ther...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07258836primaryCompletionDate: changed
LOWMay 24, 2026NCT07258836studyFirstPostDate: changed