Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy

NCT07106762 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: CA244-0012EU CTRWHO
• Study Type: interventional
• Target: 470
• Locations: 21 countries
• Sites: 157

Brief Summary

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Conditions

Urothelial Cancer

Keywords

Bladder cancer

Outcome Measures

Primary Outcomes (3)

• Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507

  Approximately 3 months

• Phase 3: Progression-Free Survival (PFS)

  Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)

  Up to 5 years

• Phase 3: Overall Survival (OS)

  Up to 5 years

Secondary Outcomes (14)

• Phase 2: Objective Response (OR)

  Up to 5 years

• Phase 2: PFS

  Up to 5 years

• Phase 2: Duration of Response (DOR)

  Up to 5 years

• Phase 2: Time to Response (TTR)

  Up to 5 years

• Phase 2: OS

  Up to 5 years

Study Arms (5)

Arm A

EXPERIMENTAL

Drug: Iza-bren

Arm B

EXPERIMENTAL

Drug: Iza-bren

Arm C

ACTIVE COMPARATOR

Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

Arm D

EXPERIMENTAL

Drug: Iza-bren

Arm E

ACTIVE COMPARATOR

Drug: Cisplatin; Drug: Gemcitabine; Drug: Carboplatin

Interventions

Iza-bren DRUG

Specified dose on specified days

Also known as: BMS-986507, BL-B01D1, Izalontamab brengitecan

Arm A; Arm B; Arm D

Cisplatin DRUG

Specified dose on specified days

Arm C; Arm E

Gemcitabine DRUG

Specified dose on specified days

Arm C; Arm E

Carboplatin DRUG

Specified dose on specified days

Arm C; Arm E

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (160)

Local Institution - 0167

Gilbert, Arizona, 85234, United States

NOT YET RECRUITING

Local Institution - 0162

Fullerton, California, 92835, United States

NOT YET RECRUITING

Local Institution - 0252

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Local Institution - 0163

Sacramento, California, 95816, United States

NOT YET RECRUITING

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Local Institution - 0251

San Francisco, California, 94115, United States

NOT YET RECRUITING

Local Institution - 0254

Santa Rosa, California, 95403, United States

NOT YET RECRUITING

Local Institution - 0245

Dillon, Colorado, 80435, United States

WITHDRAWN

Shaw Cancer Center

Edwards, Colorado, 81632, United States

RECRUITING

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Local Institution - 0247

Miami, Florida, 33176, United States

NOT YET RECRUITING

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Local Institution - 0195

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Local Institution - 0248

Buffalo, New York, 14203, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Fairview Hospital

Cleveland, Ohio, 44111, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Local Institution - 0161

Columbus, Ohio, 43210, United States

NOT YET RECRUITING

Cleveland Clinic - Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

RECRUITING

Local Institution - 0141

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Local Institution - 0186

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Local Institution - 0084

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Local Institution - 0249

Abilene, Texas, 79606, United States

NOT YET RECRUITING

Local Institution - 0187

Austin, Texas, 78705, United States

NOT YET RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Local Institution - 0253

St. George, Utah, 84790, United States

NOT YET RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

RECRUITING

Local Institution - 0188

Norfolk, Virginia, 23502, United States

NOT YET RECRUITING

Local Institution - 0200

Seattle, Washington, 98101, United States

NOT YET RECRUITING

Local Institution - 0255

Seattle, Washington, 98109, United States

NOT YET RECRUITING

Local Institution - 0028

CABA, Buenos Aires, CP1280AEB, Argentina

NOT YET RECRUITING

Local Institution - 0023

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

NOT YET RECRUITING

Local Institution - 0024

ABB, Buenos Aires F.D., C1199ABB, Argentina

NOT YET RECRUITING

Local Institution - 0026

Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina

NOT YET RECRUITING

Local Institution - 0025

Córdoba, 5000, Argentina

NOT YET RECRUITING

Local Institution - 0027

Mendoza, M5500AYB, Argentina

NOT YET RECRUITING

Macquarie University

Macquarie University, New South Wales, 2109, Australia

RECRUITING

GenesisCare North Shore

St Leonards, New South Wales, 2065, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

Medizinische Universität Wien

Vienna, State of Vienna, 1090, Austria

RECRUITING

Klinik Ottakring

Vienna, State of Vienna, 1160, Austria

RECRUITING

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

ZAS Augustinus

Wilrijk, Antwerpen, 2610, Belgium

RECRUITING

AZ Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, 4000, Belgium

RECRUITING

Local Institution - 0129

Salvador, Estado de Bahia, 41253-190, Brazil

NOT YET RECRUITING

Local Institution - 0121

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

NOT YET RECRUITING

Local Institution - 0130

Rio de Janeiro, 22451-100, Brazil

NOT YET RECRUITING

Local Institution - 0124

São Paulo, 01452-000, Brazil

NOT YET RECRUITING

Local Institution - 0020

Edmonton, Alberta, T6G 1Z2, Canada

NOT YET RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Local Institution - 0050

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Local Institution - 0224

Beijing, Beijing Municipality, 100091, China

NOT YET RECRUITING

Local Institution - 0048

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Local Institution - 0056

Xiamen, Fujian, 361003, China

NOT YET RECRUITING

Local Institution - 0051

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

Local Institution - 0201

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

Local Institution - 0059

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

Local Institution - 0046

Nanjing, Jiangsu, 210009, China

NOT YET RECRUITING

Local Institution - 0114

Nantong, Jiangsu, 226361, China

NOT YET RECRUITING

Local Institution - 0206

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Local Institution - 0156

Qingdao, Shandong, 266003, China

NOT YET RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

RECRUITING

Local Institution - 0042

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610066, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Local Institution - 0227

Tianjin, Tianjin Municipality, 300070, China

NOT YET RECRUITING

Local Institution - 0157

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Local Institution - 0064

Zhengzhou, 450008, China

NOT YET RECRUITING

Local Institution - 0115

Brno, Brno-město, 656 53, Czechia

NOT YET RECRUITING

Local Institution - 0146

Hradec Králové, Hradec Králové, 500 05, Czechia

NOT YET RECRUITING

Local Institution - 0041

Prague, Praha 5, 150 06, Czechia

NOT YET RECRUITING

Centre Antoine-Lacassagne

Nice, Alpes-Maritimes, 06189, France

RECRUITING

CHU Strasbourg-Hautepierre

Strasbourg, Alsace, 67098, France

RECRUITING

CHU de Bordeaux Hop St ANDRE

Bordeaux, Aquitaine, 33075, France

RECRUITING

Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

RECRUITING

Local Institution - 0258

Brest, Finistère, 29200, France

NOT YET RECRUITING

Hôpital Foch

Suresnes, Hauts-de-Seine, 92151, France

RECRUITING

Local Institution - 0002

Saint-Herblain, Loire-Atlantique, 44805, France

NOT YET RECRUITING

Local Institution - 0005

Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

WITHDRAWN

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, Puy-de-Dôme, 63011, France

RECRUITING

Local Institution - 0001

Villejuif, Val-de-Marne, 94800, France

NOT YET RECRUITING

Hôpital Européen Georges Pompidou

Paris, 75015, France

RECRUITING

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region, 75014, France

RECRUITING

NCT

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Studienpraxis Urologie

Nürtingen, Baden-Wurttemberg, 72622, Germany

RECRUITING

TUM Klinikum

Munich, Bavaria, 81675, Germany

RECRUITING

Klinikum Nürnberg Nord

Nuremberg, Bavaria, 90419, Germany

RECRUITING

Caritas-Krankenhaus St. Josef

Regensburg, Bavaria, 93053, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117, Germany

RECRUITING

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

RECRUITING

Krankenhaus Nordwest GmbH

Frankfurt, 60488, Germany

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Marienhospital Herne

Herne, 44625, Germany

RECRUITING

Universitaetsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

Local Institution - 0238

Cork, T12 DC4A, Ireland

NOT YET RECRUITING

Tallaght University Hospital

Dublin, D24 NR0A, Ireland

RECRUITING

Rabin Medical Center

Petah Tikva, Central District, 4941492, Israel

RECRUITING

Local Institution - 0106

Ẕerifin, Central District, 70300, Israel

NOT YET RECRUITING

Hadassah Medical Center

Jerusalem, Jerusalem, 9112001, Israel

RECRUITING

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

RECRUITING

A.O.U.C. Policlinico di Bari

Bari, Apulia, 70124, Italy

RECRUITING

Ospedale San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena

Rome, Roma, 00144, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, 56126, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS

Castelfranco Veneto, Veneto, 31033, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, 80131, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

RECRUITING

Local Institution - 0183

Kawasaki, Kanagawa, 216-8511, Japan

NOT YET RECRUITING

Local Institution - 0171

Bunkyo-ku, Tokyo, 1138603, Japan

NOT YET RECRUITING

Local Institution - 0169

Koto-ku, Tokyo, 135-8550, Japan

NOT YET RECRUITING

Local Institution - 0179

Toyoma, Toyama, 930-0194, Japan

NOT YET RECRUITING

Local Institution - 0036

Breda, North Brabant, 4818 CK, Netherlands

NOT YET RECRUITING

Local Institution - 0033

Amsterdam, North Holland, 1066 CX, Netherlands

NOT YET RECRUITING

Local Institution - 0031

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

NOT YET RECRUITING

Akershus Universitetssykehus

Lørenskog, Akershus, 1478, Norway

RECRUITING

Sykehuset i Vestfold

Tønsberg, Vestfold, 3103, Norway

RECRUITING

Sykehuset Østfold Kalnes

Sarpsborg, Østfold fylke, 1714, Norway

RECRUITING

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, 200542, Romania

RECRUITING

Institutul Oncologic Cluj

Cluj-Napoca, 400015, Romania

RECRUITING

Institutul Regional de Oncologie

Iași, 700483, Romania

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], 08041, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Local Institution - 0199

Valencia, Valenciana, Comunitat, 46009, Spain

NOT YET RECRUITING

Hospital Infanta Cristina

Badajoz, 06006, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna

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

RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], 413 45, Sweden

RECRUITING

Local Institution - 0241

Malmo, 205 02, Sweden

NOT YET RECRUITING

Cantonal Hospital St.Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Ospedale Regionale Bellinzona e Valli

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, 7000, Switzerland

RECRUITING

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

RECRUITING

Local Institution - 0243

Glasgow, Glasgow City, G12 0YN, United Kingdom

NOT YET RECRUITING

St Bartholomew's Hospital

London, London, City of, EC1A 7BE, United Kingdom

RECRUITING

Royal Marsden Hospital (Sutton)

London, Sutton, SM2 5PT, United Kingdom

RECRUITING

Local Institution - 0230

Sheffield, S10 2SJ, United Kingdom

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 6, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): January 26, 2029
• Study Completion (Estimated): November 18, 2033
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (4); BR (4); IE (2); IL (4); ES (11); AU (3); CA (4); NL (3); BE (4); CZ (3); GB (4); FR (12); AR (6); CN (24); SE (3); US (33); IT (9); NO (3); RO (3); DE (14); CH (4)