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LY4584180

Phase 1

Lymphoma, Non-Hodgkin's | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 4, 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
CONTROLLED
Total Trials1
Total Enrollment460
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07226843A Study of LY4584180 in Adult Participants With Previously Treated Blood CancersPHASE1 RECRUITING 460 — — Apr 17, 2026Feb 1, 2030Jun 4, 202646 United States, France +6
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Study Endpoints
Primary Endpoints
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Baseline up to Day 28
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to 3 Years
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
Baseline up to 3 Years
Secondary Endpoints
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180
Baseline to Day 8
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180
Baseline to Day 8
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a-Monotherapy Dose Escalation (Cohort A1)EXPERIMENTALLY4584180 monotherapy administered orally
Phase 1a-Monotherapy Dose Optimization (Cohort A2)EXPERIMENTALLY4584180 monotherapy administered orally
Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)EXPERIMENTALLY4584180 monotherapy administered orally
Phase 1b-Dose Expansion-Combination (Cohort B4)EXPERIMENTALLY4584180 administered orally in combination with rituximab administered through IV infusion
Interventions
NameTypeDescription
LY4584180DRUGadministered orally
RituximabDRUGadministered through IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites46

Inclusion Criteria: * Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy: * Diffuse large B-cell lymphoma - not otherwise specified * High-grade B-cell lymphoma * Diffuse large B-cell lymphoma - t...

Countries:United StatesFranceGermanyItalyJapanPolandSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07226843lastUpdatePostDate: changed
LOWJun 4, 2026NCT07226843lastUpdatePostDate: changed
LOWJun 4, 2026NCT07226843lastUpdatePostDate: changed
LOWJun 4, 2026NCT07226843lastUpdatePostDate: changed
LOWMay 26, 2026NCT07226843Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07226843studyFirstPostDate: changed