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LY4152199 -

Phase 1

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Eli Lilly and Company|Last Updated: May 13, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment215
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07101328A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )PHASE1 NOT YET_RECRUITING 215 — — Jun 1, 2026Sep 1, 2029May 13, 202650 United States, Australia +10
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Study Endpoints
Primary Endpoints
Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199
Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)
Secondary Endpoints
Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199
Baseline up to approximately 91 weeks
Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199
Baseline up to approximately 91 weeks
Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response (BOR) of Partial Response (PR) or Better.
Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1: Dose Escalation (Cohort A) - DLBCL and FLEXPERIMENTALEscalating doses of LY4152199 administered intravenously (IV)
Phase 1: Dose Optimization (Cohort B1) - DLBCLEXPERIMENTALTwo or more doses of LY4152199 (evaluated during dose escalation) administered IV
Phase 1: Dose Optimization (Cohort B2) - FLEXPERIMENTALTwo or more doses of LY4152199 (evaluated during dose escalation) administered IV
Interventions
NameTypeDescription
LY4152199 - IVDRUGAdministered by IV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator. * Par...

Countries:United StatesAustraliaCanadaDenmarkFranceGermanyItalyJapanPolandSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07101328primaryCompletionDate: changed
LOWMay 24, 2026NCT07101328studyFirstPostDate: changed