FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3
Start Date
1/12/2023
Completion Date
6/1/2027
Summary
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.
Detailed Description
This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered advanced solid tumor malignancy including metastatic urothelial cancer (UC). The study will be conducted in 2 phases: Phase 1a dose escalation (Cohort A1) and dose optimization (Cohort A2) and Phase 1b dose expansion. Phase 1a will assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the optimal dose for further expansion. Phase 1b will include 6 dose expansion cohorts to evaluate the efficacy and safety of LOXO-435 as monotherapy or in combinations with pembrolizumab with or without enfortumab vedotin.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
LOXO-435
Pembrolizumab
enfortumab vedotin
Conditions
Locations
University of Arizona - Cancer Center
Tucson, Arizona 85719
United States
City of Hope
Duarte, California 91010
United States
University of California, Los Angeles (UCLA) - Division of Hematology-Oncology
Los Angeles, California 90095
United States
University of California - Irvine
Orange, California 92868
United States
University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Stanford Medicine Cancer Center
Stanford, California 94305
United States
Advent Health
Orlando, Florida 32804
United States
Emory University Hospital
Atlanta, Georgia 30322
United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United States
Indiana University (IU) Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland 21231-2410
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Washington University in St. Louis
St Louis, Missouri 63108
United States
New York University (NYU)
New York, New York 10016
United States
Weill Cornell Medicine
New York, New York 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University
New York, New York 10032
United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester - Wilmot Cancer Institute
Rochester, New York 14642
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
University of North Carolina (UNC) - Chapel Hill
Chapel Hill, North Carolina 27599
United States
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio 45267
United States
The Ohio State University (OSU)
Columbus, Ohio 43210
United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer Institute
Lancaster, Pennsylvania 17601
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee 37203
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United States
University of Texas Southwestern
Dallas, Texas 75244
United States
Texas Oncology, P.A
Dallas, Texas 75251
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Utah
Salt Lake City, Utah 84132
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
St Vincent's Hospital
Darlinghurst, NSW 2010
Australia
Calvary Mater Newcastle
Hunter Region, NSW, 2310
Australia
GenesisCare North Shore
St Leonards, 2065
Australia
Macquarie University
Sydney, 2109
Australia
Princess Margaret Hospital
Toronto, M5G 2M9
Canada
British Columbia Cancer Agency
Vancouver, V5Z 1J3
Canada
Beijing Cancer hospital
Beijing, 100142
China
Beijing Hospital
Beijing, 100730
China
Sun Yat-Sen University- Cancer Center
Guangdong, 510060
China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310002
China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200000
China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060
China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
China
Zhejiang Provincial People's Hospital
Zhejiang, 310003
China
Institut Bergonie
Bordeaux, 33076
France
Centre Leon Berard
Lyon, 69373
France
Institut Gustave Roussy
Villejuif, 94805
France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, 81675
Germany
Universitaetsklinikum Tuebingen
Tübingen, 72016
Germany
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100
Israel
Sheba Medical Center
Tel Litwinsky, 5265601
Israel
IRCCS Ospedale San Raffaele
Milan, 20132
Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, 00168
Italy
National Cancer Center Hospital East
Chiba, 277-8577
Japan
Aichi Cancer Center Hospital
Nagoya, 464-8681
Japan
National Cancer Center Hospital
Tokyo, 104-0045
Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Japan
Erasmus MC
GE Rotterdam, 3015
Netherlands
Haukeland University Hospital
Bergen, 5021
Norway
Oslo University Hospital
Oslo, 0450
Norway
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
Spain
Fundacion MD Anderson International Espana
Madrid, 28033
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, 28050
Spain
Hospital Universitario Marques De Valdecilla
Santander, 39008
Spain
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2SB
United Kingdom