NCT07106762RecruitingPhase 2/3
Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy
IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 470 (estimated)
- First submitted
- 5 Aug 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 26 Jan 2029
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Bladder cancer
- NCT number
- NCT07106762
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 470
- From 30 Sept 2025 to the primary completion date, 26 Jan 2029
- 163 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 therapy with topoisomerase 1 inhibitor.
Lab values
- Participants must not have prior ADC therapy targeting EGFR or HER3.
Other
- Participants must not have active, untreated brain metastases.
- Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (163)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | ABB | Argentina | Recruiting |
| Instituto Alexander Fleming Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Hospital Británico de Buenos Aires Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Asociación de Beneficencia Hospital Sirio Libanés Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Recruiting |
| IONC Instituto Oncologico de Cordoba Fundacion Richardet Longo Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Fundacion Centro Oncologico de Integracion Regional Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Klinik Ottakring Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Medizinische Universität Wien Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Macquarie University Coordinator of this site? Confirm its status | Macquarie University | Australia | Recruiting |
| GenesisCare - North Shore Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| ZAS Augustinus Coordinator of this site? Confirm its status | Wilrijk | Belgium | Recruiting |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Salvador | Brazil | Not yet recruiting |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Ospedale Regionale Bellinzona e Valli Coordinator of this site? Confirm its status | Bellinzona | Switzerland | Recruiting |
| Kantonsspital Graubunden Coordinator of this site? Confirm its status | Chur | Switzerland | Recruiting |
| Cantonal Hospital St Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Recruiting |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| - Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| The First Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhujiang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nantong | China | Not yet recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| - Coordinator of this site? Confirm its status | Xiamen | China | Not yet recruiting |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Recruiting |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Brno | Czechia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| Krankenhaus Nordwest GmbH Coordinator of this site? Confirm its status | Frankfurt | Germany | Recruiting |
| Universitaetsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| NCT Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Marienhospital Herne Coordinator of this site? Confirm its status | Herne | Germany | Recruiting |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitaetsklinikum Schleswig Holstein Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| TUM Klinikum Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Nürnberg Nord Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| Studienpraxis Urologie Coordinator of this site? Confirm its status | Nürtingen | Germany | Recruiting |
| Caritas-Krankenhaus St. Josef Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Universitaetsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Infanta Cristina Coordinator of this site? Confirm its status | Badajoz | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| CHU de Bordeaux Hop St ANDRE Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHRU de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon Cedex08 | France | Recruiting |
| - Coordinator of this site? Confirm its status | Marseille | France | Withdrawn |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Groupe hospitalier Paris saint Joseph Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Institut de Cancérologie de l'Ouest Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| CHU Strasbourg-Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
| - Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Not yet recruiting |
| Royal Marsden Hospital (Sutton) Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| - Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Cork | Ireland | Not yet recruiting |
| Tallaght University Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| Yitzhak Shamir Medical Center Coordinator of this site? Confirm its status | Tsrifin | Israel | Recruiting |
| A.O.U.C Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Istituto Oncologico Veneto IRCCS Coordinator of this site? Confirm its status | Castelfranco Veneto | Italy | Recruiting |
| IRCCS AOM Azienda Ospedaliera Metropolitana Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Istituto Nazionale Tumori Regina Elena Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| - Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Kawasaki | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Koto-ku | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Toyoma | Japan | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Breda | Netherlands | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Not yet recruiting |
| Akershus universitetssykehus Coordinator of this site? Confirm its status | Lørenskog | Norway | Recruiting |
| Sykehuset Østfold Kalnes Coordinator of this site? Confirm its status | Sarpsborg | Norway | Recruiting |
| Sykehuset i Vestfold Coordinator of this site? Confirm its status | Tønsberg | Norway | Recruiting |
| Institutul Oncologic Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Centrul de Oncologie "Sfântul Nectarie" Coordinator of this site? Confirm its status | Craiova | Romania | Recruiting |
| Institutul Regional de Oncologie Coordinator of this site? Confirm its status | Iași | Romania | Recruiting |
| Sahlgrenska Universitetssjukhuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| - Coordinator of this site? Confirm its status | Malmö | Sweden | Not yet recruiting |
| Karolinska Universitetssjukhuset Solna Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Texas Oncology - West Texas Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Austin | United States | Not yet recruiting |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Boston | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Buffalo | United States | Withdrawn |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Fairview Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| The James Outpatient Care West Campus Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Rocky Mountain Cancer Centers, LLP Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Dillon | United States | Withdrawn |
| Shaw Cancer Center Coordinator of this site? Confirm its status | Edwards | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Fullerton | United States | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Gilbert | United States | Not yet recruiting |
| University of Kentucky Chandler Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| Cleveland Clinic - Hillcrest Hospital Coordinator of this site? Confirm its status | Mayfield Heights | United States | Recruiting |
| Miami Cancer Institute at Baptist Health, Inc. Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Nashville | United States | Not yet recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Norfolk | United States | Not yet recruiting |
| Palo Alto Center-Palo Alto Medical Foundation Research Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Portland | United States | Not yet recruiting |
| University of California Davis (UC Davis) Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Sutter Health - Sutter Institute for Medical Research Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Pacific Hematology Oncology Associates Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Sutter Santa Rosa Coordinator of this site? Confirm its status | Santa Rosa | United States | Recruiting |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| St George Regional Hospital Cancer Center Coordinator of this site? Confirm its status | St. George | United States | Recruiting |
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.