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LY4175408

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 2, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07046923A Study of LY4175408 in Participants With Advanced CancerPHASE1 RECRUITING 240 — — Jul 28, 2025Jul 1, 2030Jun 2, 202627 United States, China +4
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Study Endpoints
Primary Endpoints
Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408
1 Cycle (21 days)
Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Baseline up to approximately 4 years

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

Secondary Endpoints
Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload)
First 4 cycles (84 days)
Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload)
First 4 cycles (84 days)
Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR
Baseline up to approximately 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a Dose Escalation (Cohort A1)EXPERIMENTALEscalating doses of LY4175408 administered intravenously (IV)
Phase 1a Dose Optimization (Cohort A2)EXPERIMENTALTwo or more doses of LY4175408 (evaluated during dose escalation) administered IV
Phase 1b Dose Expansion (Cohort B1)EXPERIMENTALLY4175408 administered IV followed by pembrolizumab administered IV
Phase 1b Dose Expansion (Cohort B2)EXPERIMENTALLY4175408 administered IV followed by pembrolizumab administered IV and either carboplatin administered IV or cisplatin administered IV
Phase 1b Dose Expansion (Cohorts C1, C2 and C3)EXPERIMENTALLY4175408 administered IV
Interventions
NameTypeDescription
LY4175408DRUGIV infusion
PembrolizumabDRUGIV infusion
CarboplatinDRUGIV infusion
CisplatinDRUGIV infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Have one of the following advanced or metastatic solid tumor cancers: * Non-small cell lung cancer (NSCLC) * Small cell lung cancer (SCLC) * Endometrial cancer * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression ac...

Countries:United StatesChinaFranceJapanSouth KoreaSpain
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Recent Changes (Last 90 Days)
MEDIUMJun 2, 2026NCT07046923lastUpdatePostDate: changed
MEDIUMJun 2, 2026NCT07046923lastUpdatePostDate: changed
MEDIUMJun 2, 2026NCT07046923lastUpdatePostDate: changed
LOWMay 26, 2026NCT07046923primaryCompletionDate: changed
LOWMay 24, 2026NCT07046923studyFirstPostDate: changed