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LY4175408

Phase 1

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 23, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

LY4175408 · 1 trial · 5 indications

Phase 1 1
NCT07046923A Study of LY4175408 in Participants With Advanced CancerCarcinoma, Non-Small-Cell Lung
RECRUITING240 Analytics
PHASE1RECRUITING
A Study of LY4175408 in Participants With Advanced Cancer
Carcinoma, Non-Small-Cell LungUnlock trial analytics

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 to 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)

LOWJun 23, 2026NCT07046923lastUpdatePostDate: changed
LOWJun 23, 2026NCT07046923lastUpdatePostDate: changed

Frequently asked questions about LY4175408

What is LY4175408 used for?

LY4175408 is an investigational small molecule being developed for the treatment of advanced cancer, including non-small-cell lung carcinoma, small cell lung carcinoma, endometrial neoplasms, neoplasm metastasis, and triple negative breast cancer. It is currently in Phase 1 clinical development.

What does LY4175408 target?

The molecular target of LY4175408 has not been disclosed. It is a small molecule being studied for its potential anti-cancer activity in advanced solid tumors, including non-small-cell lung carcinoma and other cancer types.

Who makes LY4175408?

LY4175408 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.

What phase is LY4175408 in?

LY4175408 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants with advanced cancer.

What clinical trials is LY4175408 in?

LY4175408 is being evaluated in a Phase 1 clinical trial with the identifier NCT07046923, titled "A Study of LY4175408 in Participants With Advanced Cancer." The trial is recruiting and aims to enroll 240 participants across multiple countries, including the United States, China, France, Japan, South Korea, and Spain.