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

NCT ID NCT05614739

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 677 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cohort A1, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration. * Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration. * Cohorts B1 and B4: Urothelial cancer that is locally advanced or metastatic and have received prior erdafitinib. * Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration. * Cohort B7: Urothelial cancer that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration and expression of human epidermal growth factor receptor 2 (HER2). * Cohort B8: Low Grade Intermediate Risk Non-Muscle Invasive Bladder cancer and a qualifying FGFR3 genetic alteration. * Measurability of disease: * Cohort A1, D1, and D2: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1). * Cohorts A2, B1, B2, B4, B5, B7, and C1: Measurable disease required as defined by RECIST v1.1. * Cohort B8: Baseline disease which includes at least 1 lesion. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of: * 0 or 1 for Cohorts A1, A2, B5, B6, B7, and B8. * Less than or equal to 2 for Cohorts B1, B2, B4, C1, DI and D2. * Cohort B6: Must be eligible for radical cystectomy plus pelvic lymph node dissection and agree to undergo curative intent standard radical cystectomy plus pelvic lymph node dissection. Exclusion Criteria: * Participants with primary central nervous system (CNS) malignancy. * Untreated or uncontrolled CNS metastases. * Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible. * Any serious unresolved toxicities from prior therapy. * Significant cardiovascular disease. * Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF). * Active uncontrolled systemic infection or other clinically significant medical conditions. * Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled. * Cohort D1 only: * Have had renal transplantation. * Have a known history of nephrotic syndrome. * Have uncontrolled fluid overload, including clinically significant ascites, pleural effusion, or peripheral edema. * Have uncontrolled hypertension. * Are on hemodialysis or similar. * Cohort D2 only: * Have a history of: * Ventricular tachycardia or ventricular fibrillation. * Hypertrophic obstructive cardiomyopathy unless managed concurrently with atrial fibrillation. * Wolff-Parkinson-White syndrome. * Second- or third-degree atrioventricular block unless a functioning pacemaker is in place. * Heart rate less than (\<) 50 bpm. * Have any of these medical conditions: * Severe respiratory insufficiency. * Sleep apnea syndrome. * Myasthenia gravis. * Acute narrow-angle glaucoma. * Active liver disease or clinically significant hepatic impairment. * History of myopathy or rhabdomyolysis with any HMG-CoA reductase inhibitor.

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm infiltrating bladder urothelial carcinoma metastatic neoplasm neoplasm Neoplasm Metastasis Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma 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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    82 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.