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LY4101174

Phase 1

Metastatic Solid Tumor | Small molecule | Oncology |Eli Lilly and Company|Last Updated: May 22, 2026

Target and mechanism

Molecular targetNectin-4
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment490

FDA Designations

No designations recorded

Clinical trial landscape

LY4101174 · 1 trial · 14 indications

Phase 1 1
NCT06238479A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid TumorsMetastatic Solid Tumor
ACTIVE NOT_RECRUITING490 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Metastatic Solid TumorUnlock trial analytics

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 to 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 (matched to "Metastatic Solid Tumor")

Frequently asked questions about LY4101174

What is LY4101174 used for?

LY4101174 is an investigational small molecule being studied for the treatment of recurrent, advanced or metastatic solid tumors, including urinary bladder neoplasm, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer, head and neck squamous cell carcinoma, prostate cancer, renal pelvis cancer, and bladder cancer.

What does LY4101174 target?

LY4101174 targets Nectin-4, a protein involved in cell adhesion that is expressed on the surface of certain tumor cells. By targeting Nectin-4, the drug is designed to interfere with tumor growth and survival in various solid tumor types.

Who makes LY4101174?

LY4101174 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY.

What phase is LY4101174 in?

LY4101174 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is currently being evaluated in an active clinical trial for safety and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is LY4101174 in?

LY4101174 is being studied in a Phase 1 clinical trial with the identifier NCT06238479. The trial, titled 'A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors,' is active but not recruiting and has an estimated enrollment of 490 participants across multiple countries including the United States, Australia, Belgium, China, France, Japan, and Spain.

Is LY4101174 the same as any other drug?

LY4101174 is a unique investigational compound and no alternative names have been reported for it. It is distinct from other Nectin-4 targeting agents, such as enfortumab vedotin, which is an antibody-drug conjugate, whereas LY4101174 is a small molecule.