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A Study of LY4175408 in Participants With Advanced Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of LY4175408 in Participants With Advanced Cancer

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

NCT07046923•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).
•Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator; OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
•For dose optimization/dose and expansion cohorts (Cohort A2, Cohort B): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

•Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted).
•Any serious unresolved toxicities from prior therapy.
•Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.
•Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
•Significant cardiovascular disease.
•Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 470 milliseconds (ms)
•History of pneumonitis/interstitial lung disease.
•Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.

Locations (24)

Stanford Cancer Center

Stanford, California, United States

Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute

Orlando, Florida, United States

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

John Theurer Cancer Center At Hackensack UMC

Hackensack, New Jersey, United States

Columbia University

New York, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

July 28, 2025

Primary Completion Date

July 1, 2030

Completion Date

July 1, 2030

Last Updated

March 2, 2026

Enrollment

240

ESTIMATED participants

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaEndometrial NeoplasmsNeoplasm MetastasisTriple Negative Breast Cancer

Interventions

LY4175408

DRUG

Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of LY4175408 in Participants With Advanced Cancer

Inclusion Criteria

Exclusion Criteria

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

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