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LY4337713

Phase 1

Ovarian Neoplasms | 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment241
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07213791A Study of LY4337713 in Participants With FAP-Positive Solid TumorsPHASE1 RECRUITING 241 — — Oct 22, 2025Mar 1, 2033Jun 4, 202630 United States, China +3
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Study Endpoints
Primary Endpoints
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
Cycle 1 (28 days)
Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Baseline through imaging follow-up, up to 5 years

Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Secondary Endpoints
Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs
Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)
Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713
Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
Phase 1a: PK: Area Under the Concentration Time Curve (AUC) of LY4337713
Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4337713 (Cohort A1)EXPERIMENTALEscalating doses of LY4337713 administered intravenously (IV).
LY4337713 (Cohort A2)EXPERIMENTALTwo or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.
Experimental: LY4337713 (Cohort B)EXPERIMENTALTumor specific cohort will receive LY4337713 administered IV.
Experimental LY4337713 (Cohort C)EXPERIMENTALTumor specific cohort will receive LY4337713 administered IV.
Experimental: LY4337713 (Cohort D)EXPERIMENTALTumor specific cohort will receive LY4337713 administered IV.
LY4337713 (Cohort E)EXPERIMENTALTumor specific cohort will receive LY4337713 administered IV.
Interventions
NameTypeDescription
LY4337713DRUGAdministered IV.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment * Must have histologically or cytologically confirmed diagnosis of one of the following: * Adenocarcinoma of the pancreas * Hormone receptor (HR)-positive human e...

Countries:United StatesChinaGermanyJapanNetherlands
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07213791lastUpdatePostDate: changed
LOWJun 4, 2026NCT07213791lastUpdatePostDate: changed
LOWJun 4, 2026NCT07213791lastUpdatePostDate: changed
LOWJun 4, 2026NCT07213791lastUpdatePostDate: changed
LOWMay 26, 2026NCT07213791primaryCompletionDate: changed
LOWMay 24, 2026NCT07213791studyFirstPostDate: changed