A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Start Date
7/1/2024
Completion Date
5/1/2027
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.
Detailed Description
This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
LY4052031
Conditions
Locations
City of Hope National Medical Center
Duarte, California 91010-0269
United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California 92093
United States
UCLA Department of Medicine-Hematology/Oncology
Los Angeles, California 90024
United States
Sarah Cannon Research Institute at HealthOne
Denver, Colorado 80218
United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida 33705
United States
University of Chicago Hospital
Chicago, Illinois 60637
United States
IU Simon Cancer Center
Indianapolis, Indiana 46202
United States
Massachusetts General Hospital
Boston, Massachusetts 02215
United States
START Midwest Cancer and Hematology Centers of W Michigan
Grand Rapids, Michigan 49546
United States
Washington University School of Medicine in St. Louis
St Louis, Missouri 63110
United States
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York, New York 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029-6574
United States
Columbia University Irving Medical Center
New York, New York 10032-3729
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Tennessee Oncology PLLC
Nashville, Tennessee 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030-4000
United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 78229
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
START Mountain Region
West Valley City, Utah 84119
United States
St Vincent's Hospital
Darlinghurst, 2010
Australia
Linear Clinical Research
Nedlands, 6009
Australia
Beijing Cancer hospital
Beijing, 100142
China
Sun Yat-sen University Cancer Center
Guangzhou, 510060
China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200000
China
Institut Gustave Roussy (Igr)
Villejuif, 94805
France
National Cancer Center Hospital
Chūōku, 104-0045
Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Japan
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550
Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681
Japan
Asan Medical Center
Seoul, 05505
South Korea
Catalan Institute of Oncology Duran i Reynals Hospital
Barcelona, 8908
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Madrid Norte Sanchinarro
Madrid, 28050
Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013
Spain
St Bartholomew's Hospital
London, EC1A 7BE
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom