New drug LOXO-435 targets Hard-to-Treat bladder cancers

NCT ID NCT05614739

Recruiting now Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new oral drug called LOXO-435, alone or with other cancer medicines, in people with advanced solid tumors that have a specific change in the FGFR3 gene. The study aims to find the right dose and check for safety and early signs of effectiveness. Up to 535 participants with bladder or other cancers will take part for about 2.5 years.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

LOXO-435 (a targeted drug taken by mouth)

What this could lead to

If it works, this could point toward a new treatment option for people with advanced bladder or other cancers that have a specific FGFR3 gene change.

What could go wrong

This is an early Phase 1 trial, so the drug may not work as hoped or could have unexpected side effects. It is also only for people with a specific gene change, so it would not help everyone.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm metastatic neoplasm Neoplasm Metastasis ureter cancer ureter neoplasm urinary bladder neoplasm Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NEOPLASM METASTASIS URETERAL NEOPLASMS URINARY BLADDER NEOPLASMS

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••
Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Advent Health
RECRUITING

Orlando, Florida, 32804, United States
Aichi Cancer Center Hospital
RECRUITING

Nagoya, 464-8681, Japan
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Asan Medical Center
RECRUITING

Seoul, 05505, South Korea
Barbara Ann Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
Beijing Cancer hospital
RECRUITING

Beijing, 100142, China
Beijing Hospital
RECRUITING

Beijing, 100730, China
British Columbia Cancer Agency
RECRUITING

Vancouver, V5Z 1J3, Canada
Calvary Mater Newcastle
RECRUITING

Hunter Region, NSW, 2310, Australia
Cancer Institute Hospital of JFCR
RECRUITING

Tokyo, 135-8550, Japan
Carolina Urologic Research Center
RECRUITING

Myrtle Beach, South Carolina, 29572, United States
Centre Leon Berard
RECRUITING

Lyon, 69373, France
City of Hope
RECRUITING

Duarte, California, 91010, United States
Columbia University
RECRUITING

New York, New York, 10032, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Emory University Hospital
RECRUITING

Atlanta, Georgia, 30322, United States
Erasmus MC
RECRUITING

GE Rotterdam, 3015, Netherlands
Fundacion MD Anderson International Espana
RECRUITING

Madrid, 28033, Spain
GenesisCare North Shore
RECRUITING

St Leonards, 2065, Australia
Haukeland University Hospital
RECRUITING

Bergen, 5021, Norway
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Marques De Valdecilla
RECRUITING

Santander, 39008, Spain
IRCCS Ospedale San Raffaele
RECRUITING

Milan, 20132, Italy
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Indiana University (IU) Melvin and Bren Simon Cancer Center
RECRUITING

Indianapolis, Indiana, 46202, United States
Institut Bergonie
RECRUITING

Bordeaux, 33076, France
Institut Catala d'Oncologia - L'Hospitalet
RECRUITING

Barcelona, 08908, Spain
Institut Gustave Roussy
RECRUITING

Villejuif, 94805, France
Johns Hopkins Kimmel Cancer Center
RECRUITING

Baltimore, Maryland, 21231-2410, United States
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
RECRUITING

München, 81675, Germany
MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
Macquarie University
RECRUITING

Sydney, 2109, Australia
Mary Bird Perkins Cancer Center
RECRUITING

Baton Rouge, Louisiana, 70809, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Montefiore Medical Center
RECRUITING

The Bronx, New York, 10467, United States
National Cancer Center Hospital
RECRUITING

Tokyo, 104-0045, Japan
National Cancer Center Hospital East
RECRUITING

Chiba, 277-8577, Japan
New York University (NYU)
RECRUITING

New York, New York, 10016, United States
Ochsner Clinic Foundation
RECRUITING

New Orleans, Louisiana, 70121, United States
Oslo University Hospital
RECRUITING

Oslo, 0450, Norway
Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer Institute
RECRUITING

Lancaster, Pennsylvania, 17601, United States
Princess Margaret Hospital
RECRUITING

Toronto, M5G 2M9, Canada
Rabin Medical Center, Beilinson Hospital
RECRUITING

Petah Tikva, 49100, Israel
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING

Shanghai, 200000, China
Samsung Medical Center
RECRUITING

Seoul, 06351, South Korea
Sarah Cannon and HCA Research Institute
RECRUITING

Nashville, Tennessee, 37203, United States
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Sheba Medical Center
RECRUITING

Tel Litwinsky, 5265601, Israel
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING

Sheffield, S10 2SB, United Kingdom
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITING

Hangzhou, 310002, China
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
RECRUITING

Madrid, 28050, Spain
St Vincent's Hospital
RECRUITING

Darlinghurst, NSW 2010, Australia
Stanford Medicine Cancer Center
RECRUITING

Stanford, California, 94305, United States
Sun Yat-Sen University- Cancer Center
RECRUITING

Guangdong, 510060, China
Tennessee Oncology
RECRUITING

Nashville, Tennessee, 37203, United States
Texas Oncology, P.A
RECRUITING

Dallas, Texas, 75251, United States
The Christie NHS Foundation Trust
RECRUITING

Manchester, M20 4BX, United Kingdom
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING

Xi'an, 710061, China
The Ohio State University (OSU)
RECRUITING

Columbus, Ohio, 43210, United States
The University of Chicago Medical Center (UCMC)
RECRUITING

Chicago, Illinois, 60637, United States
Thomas Jefferson University
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, 300060, China
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
RECRUITING

Roma, 00168, Italy
Universitaetsklinikum Tuebingen
RECRUITING

Tübingen, 72016, Germany
University of Arizona - Cancer Center
RECRUITING

Tucson, Arizona, 85719, United States
University of California (UC) Davis Comprehensive Cancer Center
RECRUITING

Sacramento, California, 95817, United States
University of California - Irvine
RECRUITING

Orange, California, 92868, United States
University of California, Los Angeles (UCLA) - Division of Hematology-Oncology
RECRUITING

Los Angeles, California, 90095, United States
University of Cincinnati Medical Center (UCMC)
RECRUITING

Cincinnati, Ohio, 45267, United States
University of North Carolina (UNC) - Chapel Hill
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University of Oklahoma - Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Rochester - Wilmot Cancer Institute
RECRUITING

Rochester, New York, 14642, United States
University of Texas Southwestern
RECRUITING

Dallas, Texas, 75244, United States
University of Utah
RECRUITING

Salt Lake City, Utah, 84132, United States
University of Vermont Medical Center
RECRUITING

Burlington, Vermont, 05401, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37212, United States
Washington University in St. Louis
RECRUITING

St Louis, Missouri, 63108, United States
Weill Cornell Medicine
RECRUITING

New York, New York, 10021, United States
Zhejiang Provincial People's Hospital
RECRUITING

Zhejiang, 310003, China