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LY4101174

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: May 22, 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 Enrollment490
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06238479A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 490 — — Mar 5, 2024Apr 1, 2027May 22, 202628 United States, Australia +5
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Study Endpoints
Primary Endpoints
Phase 1a: To determine the recommended dose of LY4101174
First 2 Cycles (28 days)

Number of participants with dose-limiting toxicities (DLTs)

Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174
First 2 Cycles (28 days)

Number of participants with DLTs

Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR)
Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Secondary Endpoints
To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)
First 4 cycles (56 days)
To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)
First 4 cycles (56 days)
To evaluate the preliminary antitumor activity of LY4101174: Overall response rate (ORR)
Up to Approximately 48 Months or 4 Years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4101174 (Dose-escalation, Cohort A1)EXPERIMENTALEscalating doses of LY4101174 administered intravenously (IV).
LY4101174 (Dose-optimization, Cohort A2)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.
LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5)EXPERIMENTALLY4101174 administered IV.
Interventions
NameTypeDescription
LY4101174DRUGIntravenous
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Have one of the following solid tumor cancers: * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinom...

Countries:United StatesAustraliaBelgiumChinaFranceJapanSpain
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06238479Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06238479studyFirstPostDate: changed