New drug aims to outsmart chemo in tough bladder cancer

NCT ID NCT07106762

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 5 times

Summary

This study compares a new drug, izalontamab brengitecan, against standard platinum-based chemotherapy in 470 people with metastatic urothelial cancer that has worsened after immunotherapy. The goal is to see if the new drug can slow cancer growth or improve survival. Participants are randomly assigned to receive either the new drug or chemotherapy.

What this could mean

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

Active substance: izalontamab brengitecan (a drug that targets cancer cells)
What this could lead to: If successful, this could offer a new treatment option for people with advanced bladder cancer that has stopped responding to immunotherapy.
What could go wrong: This is an early-to-mid stage trial, so the drug may not prove more effective than standard chemotherapy. Side effects from the new drug are still being studied.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 470 people

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

Started

Sep 2025

Expected to finish

Nov 2033

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: * Participants must have histologically confirmed advanced urothelial carcinoma. * Participants must be eligible to receive platinum-based chemotherapy. * Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy. * Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment. * Participants must have ≥ 1 measurable lesion per RECIST v1.1. * Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Exclusion Criteria: * Participants must not have platinum-based chemotherapy exposure within 12 months. * Participants must not have received \>2 prior regimens irrespective of the setting. * Participants must not have prior ADC therapy targeting EGFR or HER3. * Participants must not have prior therapy with topoisomerase 1 inhibitor. * Participants must not have active, untreated brain metastases. * Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Urinary Bladder Neoplasms urothelial carcinoma

As listed by the trial registrant

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

Urothelial cancer

How to take part

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

The places running it

160 sites in 22 countries. The list below names each one and where it is.
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 ↗
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

A.O.U.C. Policlinico di Bari
RECRUITING

Bari, Apulia, 70124, Italy
AZ Maria Middelares
RECRUITING

Ghent, Oost-Vlaanderen, 9000, Belgium
Akershus Universitetssykehus
RECRUITING

Lørenskog, Akershus, 1478, Norway
Asociación de Beneficencia Hospital Sirio Libanés
RECRUITING

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1419, Argentina
Austin Health
RECRUITING

Heidelberg, Victoria, 3084, Australia
Azienda Ospedaliera Universitaria Federico II
RECRUITING

Naples, 80131, Italy
Azienda Ospedaliero Universitaria Pisana
RECRUITING

Pisa, Tuscany, 56126, Italy
Azienda Ospedaliero Universitaria di Parma
RECRUITING

Parma, 43126, Italy
CHRU de Brest
RECRUITING

Brest, Finistère, 29200, France
CHU Strasbourg-Hautepierre
RECRUITING

Strasbourg, Alsace, 67098, France
CHU de Bordeaux Hop St ANDRE
RECRUITING

Bordeaux, Aquitaine, 33075, France
Cantonal Hospital St.Gallen
RECRUITING

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Caritas-Krankenhaus St. Josef
RECRUITING

Regensburg, Bavaria, 93053, Germany
Centre Antoine-Lacassagne
RECRUITING

Nice, Alpes-Maritimes, 06189, France
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
RECRUITING

Liège, 4000, Belgium
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
RECRUITING

Clermont-Ferrand, Puy-de-Dôme, 63011, France
Centre Leon Berard
RECRUITING

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France
Centrul de Oncologie "Sfântul Nectarie"
RECRUITING

Craiova, Dolj, 200542, Romania
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
RECRUITING

Berlin, 10117, Germany
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Cleveland Clinic - Hillcrest Hospital
RECRUITING

Mayfield Heights, Ohio, 44124, United States
Fairview Hospital
RECRUITING

Cleveland, Ohio, 44111, United States
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING

Milan, 20133, Italy
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Fundacion Centro Oncologico de Integración Regional
RECRUITING

Mendoza, M5500AYB, Argentina
Fundación Instituto Valenciano de Oncología
RECRUITING

Valencia, Valenciana, Comunitat, 46009, Spain
GenesisCare North Shore
RECRUITING

St Leonards, New South Wales, 2065, Australia
Groupe hospitalier Paris saint Joseph
RECRUITING

Paris, Île-de-France Region, 75014, France
Gustave Roussy
RECRUITING

Villejuif, Val-de-Marne, 94800, France
Hadassah Medical Center
RECRUITING

Jerusalem, Jerusalem, 9112001, Israel
Hospital Británico de Buenos Aires
RECRUITING

CABA, Buenos Aires, CP1280AEB, Argentina
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital General Universitario Gregorio Marañon
RECRUITING

Madrid, 28007, Spain
Hospital Infanta Cristina
RECRUITING

Badajoz, 06006, Spain
Hospital Italiano de Buenos Aires
RECRUITING

ABB, Buenos Aires F.D., C1199ABB, Argentina
Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Marqués de Valdecilla
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Ramón y Cajal
RECRUITING

Madrid, Madrid, Comunidad de, 28034, Spain
Hospital Universitario Reina Sofia
RECRUITING

Córdoba, 14004, Spain
Hospital Universitario Virgen Del Rocio
RECRUITING

Seville, 41013, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, Catalunya [Cataluña], 08041, Spain
Hôpital Européen Georges Pompidou
RECRUITING

Paris, 75015, France
Hôpital Foch
RECRUITING

Suresnes, Hauts-de-Seine, 92151, France
IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo
RECRUITING

Córdoba, 5000, Argentina
IRCCS AOM Azienda Ospedaliera Metropolitana
RECRUITING

Genoa, Liguria, 16132, Italy
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Institut de Cancérologie de l'Ouest
RECRUITING

Saint-Herblain, Loire-Atlantique, 44805, France
Instituto Alexander Fleming
RECRUITING

Caba, Buenos Aires, 1426, Argentina
Institutul Oncologic Cluj
RECRUITING

Cluj-Napoca, 400015, Romania
Institutul Regional de Oncologie
RECRUITING

Iași, 700483, Romania
Intermountain Medical Center
RECRUITING

Murray, Utah, 84107, United States
Istituto Nazionale Tumori Regina Elena
RECRUITING

Rome, Roma, 00144, Italy
Istituto Oncologico Veneto IRCCS
RECRUITING

Castelfranco Veneto, Veneto, 31033, Italy
Johns Hopkins Hospital
RECRUITING

Baltimore, Maryland, 21287, United States
Kantonsspital Graubünden
RECRUITING

Chur, 7000, Switzerland
Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
Karolinska Universitetssjukhuset Solna
RECRUITING

Solna, Stockholms Län [se-01], 171 64, Sweden
Klinik Ottakring
RECRUITING

Vienna, State of Vienna, 1160, Austria
Klinikum Nürnberg Nord
RECRUITING

Nuremberg, Bavaria, 90419, Germany
Krankenhaus Nordwest GmbH
RECRUITING

Frankfurt, 60488, Germany
Local Institution - 0005
WITHDRAWN

Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France
Local Institution - 0020
NOT_YET_RECRUITING

Edmonton, Alberta, T6G 1Z2, Canada
Local Institution - 0031
NOT_YET_RECRUITING

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands
Local Institution - 0033
NOT_YET_RECRUITING

Amsterdam, North Holland, 1066 CX, Netherlands
Local Institution - 0036
NOT_YET_RECRUITING

Breda, North Brabant, 4818 CK, Netherlands
Local Institution - 0041
NOT_YET_RECRUITING

Prague, Praha 5, 150 06, Czechia
Local Institution - 0042
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0046
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210009, China
Local Institution - 0048
NOT_YET_RECRUITING

Fuzhou, Fujian, 350001, China
Local Institution - 0050
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100034, China
Local Institution - 0056
NOT_YET_RECRUITING

Xiamen, Fujian, 361003, China
Local Institution - 0059
NOT_YET_RECRUITING

Changsha, Hunan, 410013, China
Local Institution - 0064
NOT_YET_RECRUITING

Zhengzhou, Henan, 450008, China
Local Institution - 0084
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Local Institution - 0114
NOT_YET_RECRUITING

Nantong, Jiangsu, 226361, China
Local Institution - 0115
NOT_YET_RECRUITING

Brno, Brno-město, 656 53, Czechia
Local Institution - 0121
NOT_YET_RECRUITING

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Local Institution - 0124
NOT_YET_RECRUITING

São Paulo, 01452-000, Brazil
Local Institution - 0129
NOT_YET_RECRUITING

Salvador, Estado de Bahia, 41253-190, Brazil
Local Institution - 0130
NOT_YET_RECRUITING

Rio de Janeiro, 22451-100, Brazil
Local Institution - 0141
NOT_YET_RECRUITING

Portland, Oregon, 97239, United States
Local Institution - 0146
NOT_YET_RECRUITING

Hradec Králové, Hradec Králové, 500 05, Czechia
Local Institution - 0157
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310022, China
Local Institution - 0162
NOT_YET_RECRUITING

Fullerton, California, 92835, United States
Local Institution - 0167
NOT_YET_RECRUITING

Gilbert, Arizona, 85234, United States
Local Institution - 0169
NOT_YET_RECRUITING

Koto-ku, Tokyo, 135-8550, Japan
Local Institution - 0171
NOT_YET_RECRUITING

Bunkyo-ku, Tokyo, 1138603, Japan
Local Institution - 0179
NOT_YET_RECRUITING

Toyoma, Toyama, 930-0194, Japan
Local Institution - 0183
NOT_YET_RECRUITING

Kawasaki, Kanagawa, 216-8511, Japan
Local Institution - 0187
NOT_YET_RECRUITING

Austin, Texas, 78705, United States
Local Institution - 0188
NOT_YET_RECRUITING

Norfolk, Virginia, 23502, United States
Local Institution - 0195
NOT_YET_RECRUITING

Boston, Massachusetts, 02215, United States
Local Institution - 0200
NOT_YET_RECRUITING

Seattle, Washington, 98101, United States
Local Institution - 0224
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100091, China
Local Institution - 0227
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300070, China
Local Institution - 0230
NOT_YET_RECRUITING

Sheffield, S10 2SJ, United Kingdom
Local Institution - 0238
NOT_YET_RECRUITING

Cork, T12 DC4A, Ireland
Local Institution - 0241
NOT_YET_RECRUITING

Malmö, 205 02, Sweden
Local Institution - 0243
NOT_YET_RECRUITING

Glasgow, Glasgow City, G12 0YN, United Kingdom
Local Institution - 0245
WITHDRAWN

Dillon, Colorado, 80435, United States
Local Institution - 0248
WITHDRAWN

Buffalo, New York, 14203, United States
Macquarie University
RECRUITING

Macquarie University, New South Wales, 2109, Australia
Marienhospital Herne
RECRUITING

Herne, 44625, Germany
McGill University Health Centre
RECRUITING

Montreal, Quebec, H4A 3J1, Canada
Medizinische Hochschule Hannover
RECRUITING

Hanover, Lower Saxony, 30625, Germany
Medizinische Universitaet Innsbruck
RECRUITING

Innsbruck, Tyrol, 6020, Austria
Medizinische Universität Wien
RECRUITING

Vienna, State of Vienna, 1090, Austria
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Miami Cancer Institute at Baptist Health, Inc.
RECRUITING

Miami, Florida, 33176, United States
NCT
RECRUITING

Heidelberg, Baden-Wurttemberg, 69120, Germany
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING

Nanjing, Jiangsu, 210000, China
Ospedale Regionale Bellinzona e Valli
RECRUITING

Bellinzona, Canton Ticino, 6500, Switzerland
Ospedale San Raffaele
RECRUITING

Milan, 20132, Italy
Pacific Hematology Oncology Associates
RECRUITING

San Francisco, California, 94115, United States
Palo Alto Center-Palo Alto Medical Foundation Research Institute
RECRUITING

Palo Alto, California, 94304, United States
Princess Margaret Cancer Centre
RECRUITING

Toronto, Ontario, M5G 2M9, Canada
Rabin Medical Center
RECRUITING

Petah Tikva, Central District, 4941492, Israel
Rambam Health Care Campus
RECRUITING

Haifa, Northern District, 3109601, Israel
Rocky Mountain Cancer Centers, LLP
RECRUITING

Denver, Colorado, 80218, United States
Royal Marsden Hospital (Sutton)
RECRUITING

London, Sutton, SM2 5PT, United Kingdom
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Sahlgrenska Universitetssjukhuset
RECRUITING

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden
Shandong Cancer Hospital
RECRUITING

Jinan, Shandong, 250117, China
Shaw Cancer Center
RECRUITING

Edwards, Colorado, 81632, United States
Sibley Memorial Hospital
RECRUITING

Washington D.C., District of Columbia, 20016, United States
Sichuan Cancer hospital
RECRUITING

Chengdu, Sichuan, 610041, China
St Bartholomew's Hospital
RECRUITING

London, London, City of, EC1A 7BE, United Kingdom
St George Regional Hospital Cancer Center
RECRUITING

St. George, Utah, 84790, United States
Studienpraxis Urologie
RECRUITING

Nürtingen, Baden-Wurttemberg, 72622, Germany
Sun Yat-sen University Cancer Center
RECRUITING

Guangzhou, Guangdong, 510060, China
Sutter Health - Sutter Institute for Medical Research
RECRUITING

Sacramento, California, 95816, United States
Sutter Santa Rosa
RECRUITING

Santa Rosa, California, 95403, United States
Sykehuset i Vestfold
RECRUITING

Tønsberg, Vestfold, 3103, Norway
Sykehuset Østfold Kalnes
RECRUITING

Sarpsborg, Østfold fylke, 1714, Norway
TUM Klinikum
RECRUITING

Munich, Bavaria, 81675, Germany
Tallaght University Hospital
RECRUITING

Dublin, D24 NR0A, Ireland
Texas Oncology - West Texas
RECRUITING

Abilene, Texas, 79606, United States
The Affiliated Hospital of Qingdao University
RECRUITING

Qingdao, Shandong, 266003, China
The First Affiliated Hospital Of Fujian Medical University
RECRUITING

Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING

Guangzhou, Guangdong, 510120, China
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING

Wenzhou, Zhejiang, 325000, China
The James Outpatient Care West Campus
RECRUITING

Columbus, Ohio, 43221, United States
The Ottawa Hospital Cancer Centre
RECRUITING

Ottawa, Ontario, K1H 8L6, Canada
Tianjin Medical University Cancer Institute & Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300060, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
RECRUITING

Wuhan, 430030, China
UZ Gent
RECRUITING

Ghent, Oost-Vlaanderen, 9000, Belgium
Universitaetsklinikum Duesseldorf
RECRUITING

Düsseldorf, 40225, Germany
Universitaetsklinikum Hamburg-Eppendorf
RECRUITING

Hamburg, 20246, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
RECRUITING

Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Ulm
RECRUITING

Ulm, 89081, Germany
University of California Davis (UC Davis) Comprehensive Cancer Center
RECRUITING

Sacramento, California, 95817, United States
University of Kentucky Chandler Medical Center
RECRUITING

Lexington, Kentucky, 40536, United States
University of Virginia Health System
RECRUITING

Charlottesville, Virginia, 22903, United States
University of Washington Medical Center - Montlake
RECRUITING

Seattle, Washington, 98195, United States
UniversitätsSpital Zürich
RECRUITING

Zurich, 8091, Switzerland
Universitätsklinikum Jena
RECRUITING

Jena, Thuringia, 07747, Germany
West China Hospital, Sichuan University
RECRUITING

Chengdu, Sichuan, 610066, China
Yantai Yuhuangding Hospital
RECRUITING

Yantai, Shandong, 264000, China
Yitzhak Shamir Medical Center
RECRUITING

Ẕerifin, Central District, 70300, Israel
ZAS Augustinus
RECRUITING

Wilrijk, Antwerpen, 2610, Belgium
Zhujiang Hospital
RECRUITING

Guangzhou, Guangdong, 510280, China

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