RecruitingPhase 1NCT06465069

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Sponsor

Eli Lilly and Company

Enrollment

420 participants

Start Date

Jul 1, 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, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. 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 early-phase study is testing a new investigational drug (LY4052031) in several types of advanced or metastatic solid tumors. It aims to determine safe doses, side effects, and whether the drug shows early signs of effectiveness. **You may be eligible if...** - You have an advanced or metastatic solid tumor such as: urothelial (bladder) cancer, triple negative breast cancer, non-small cell lung cancer, esophageal, pancreatic, ovarian, cervical, head and neck, or prostate cancer - Your cancer has progressed on standard treatments - You are in good enough health to tolerate an experimental treatment **You may NOT be eligible if...** - Your cancer type is not on the eligible list - You have serious uncontrolled medical conditions 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

DRUGLY4052031

Intravenous

Locations(31)

City of Hope National Medical Center

Duarte, California, United States

Sarah Cannon Research Institute at HealthOne

Denver, Colorado, United States

Florida Cancer Specialists and Research Institute

St. Petersburg, Florida, United States

University of Chicago Hospital

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

START Midwest Cancer and Hematology Centers of W Michigan

Grand Rapids, Michigan, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

START Mountain Region

West Valley City, Utah, United States

St Vincent's Hospital

Darlinghurst, Australia

Linear Clinical Research

Nedlands, Australia

Beijing Cancer hospital

Beijing, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Institut Gustave Roussy (Igr)

Villejuif, France

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

The Cancer Institute Hospital of JFCR

Kōtō City, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Asan Medical Center

Seoul, South Korea

Catalan Institute of Oncology Duran i Reynals Hospital

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Madrid Norte Sanchinarro

Madrid, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

St Bartholomew's Hospital

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06465069

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