RecruitingPhase 1NCT06238479

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Sponsor

Eli Lilly and Company

Enrollment

490 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Recurrent Solid Tumor Urinary Bladder Neoplasm

Summary

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called LY4101174 in people with advanced or metastatic solid tumors. The trial is looking at multiple cancer types across different groups (cohorts), including bladder cancer, triple-negative breast cancer, lung cancer, ovarian cancer, cervical cancer, and head and neck cancer. **You may be eligible if...** - You have one of the following cancers in an advanced or metastatic stage: bladder/urothelial cancer, triple-negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer, head and neck squamous cell carcinoma, or prostate cancer - You have received standard therapies or there are no further standard options available - You have measurable disease on scans - Your organs are functioning adequately **You may NOT be eligible if...** - You have not received prior standard therapy (for most cohorts) - Your cancer type does not match any of the eligible cohorts - You have serious organ dysfunction or other medical conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4101174

Intravenous

Locations(28)

AdventHealth Orlando

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

UT Southwestern Medical Center

Dallas, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Austin Health

Heidelberg, Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, Australia

Institut Jules Bordet

Anderlecht, Belgium

Peking University First Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

Shanghai East Hospital

Shanghai, China

Centre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Institut Paoli-Calmettes

Marseille, France

CHU Strasbourg-Hautepierre

Strasbourg, France

Gustave Roussy

Villejuif, France

National Cancer Center Hospital

Chūōku, Japan

National Cancer Center Hospital East

Kashiwa, Japan

The Cancer Institute Hospital of JFCR

Kōtō City, Japan

Kyoto University Hospital

Kyoto, Japan

Hospital Universitari Vall d'Hebron

Barcelona, Spain

MD Anderson Cancer Center

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

View Full Details on ClinicalTrials.gov

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NCT06238479

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