Spots Global Cancer Trial Database for A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3
Official Title: An Open-Label, Multicenter Study of LOXO-435 (LY3866288) In Advanced Solid Tumor Malignancies With FGFR3 Alterations
Study ID: NCT05614739
Study Description
Brief Summary: The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. 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 1a/b study in participants with FGFR3-altered advanced solid tumors, including metastatic urothelial cancer (UC). The study will be conducted in 2 phases: Dose escalation and dose optimization (1a) and dose expansion (1b). Phase 1a will include up to 2 cohorts to assess safety, tolerability, and pharmacokinetics of LOXO-435 to determine the recommended phase 2 dose (RP2D) (or optimal dose). Phase 1b will include 4 dose expansion cohorts of participants with prespecified activating FGFR3 alterations to evaluate the efficacy and safety of LOXO-435 at the RP2D. Cohort B will enroll pts with metastatic UC and includes three cohorts to evaluate LOXO-435 as monotherapy (B1, B2) and in combination with pembrolizumab (B3). Cohort C will enroll pts with non-UC advanced solid tumors and includes a cohort to evaluate LOXO-435 as monotherapy (C1).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Medical Center, Duarte, California, United States
UCLA Department of Medicine-Hematology/Oncology, Santa Monica, California, United States
Advent Health Hematology and Oncology, Celebration, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
SKCCC at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Penn Medicine: University of Pennsylvania Health System/Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Royal North Shore Hospital, Saint Leonards, New South Wales, Australia
Kinghorn Cancer Centre, Darlinghurst, , Australia
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Beijing Cancer hospital, Beijing, Beijing, China
Beijing Cancer hospital, Haidian, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Renji Hospital Affliated to Shanghai Jiaotong University, Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Zhejiang University, Hangzhou, Zhejiang, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Zhejiang, China
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, Aquitaine, France
Gustave Roussy, Villejuif, Shanxi, France
Centre Leon Berard, Lyon, , France
Klinikum rechts der Isar de Technischen Universitaet Muenchen, München, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Beilinson Hospital, Petach Tikva, HaMerkaz, Israel
Sheba Medical Center, Ramat Gan, HaMerkaz, Israel
IRCCS Ospedale San Raffaele, Milano, Milan, Italy
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Roma, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
National Cancer Center Hospital East, Chiba, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Asan Medical Center, Seoul, Seoul], Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Erasmus Medisch Centrum, Rotterdam, Zuid-Holland, Netherlands
Oslo University Hospital Ullevaal, Oslo, Roma, Norway
Haukeland University, Bergen, , Norway
Institut Catala d'Oncologia L'Hospitalet, Barcelona, , Spain
Centro Oncológico MD Anderson, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
South Texas Accelerated Research Therapeutics (START) Madrid, Madrid, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
Contact Details
Name: Ryan Widau, PhD
Affiliation: Loxo Oncology, Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
