A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) — Stella
Phase 2 — Testing in a larger group (up to a few hundred people) to further evaluate safety and begin to assess effectiveness.
(293 sites) United States
Local Institution - 0303, Hot Springs, Arkansas Helios Clinical Research, Cerritos, California Local Institution - 0307, Cerritos, California Local Institution - 0308, Cerritos, California Local Institution - 0309, Cerritos, California Local Institution - 0311, Long Beach, California USC/Norris Comprehensive Cancer Center, Los Angeles, California Valkyrie Clinical Trials, Los Angeles, California USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California Local Institution - 0358, Stanford, California Local Institution - 0289, Aurora, Colorado Rocky Mountain Cancer Centers, Denver, Colorado Medical Oncology Hematology Consultants, PA, Newark, Delaware Local Institution - 0296, Pembroke Pines, Florida Local Institution - 0294, Atlanta, Georgia Northside Hospital, Atlanta, Georgia Local Institution - 0278, Chicago, Illinois Local Institution - 0280, Chicago, Illinois Decatur Memorial Hospital, Decatur, Illinois Local Institution - 0324, O'Fallon, Illinois Ochsner Clinic Foundation, Covington, Louisiana Local Institution - 1035, Baltimore, Maryland Massachusetts General Hospital, Boston, Massachusetts Dana-Farber Cancer Institute, Boston, Massachusetts Local Institution - 0359, Detroit, Michigan Minnesota Oncology Hematology, Maple Grove, Minnesota Local Institution - 0372, Minneapolis, Minnesota Saint Luke's Cancer Institute, Kansas City, Missouri Local Institution - 0312, New York, New York Local Institution - 0279, New York, New York Clinical Research Alliance, Westbury, New York White Plains Hospital, White Plains, New York Local Institution - 0276, Durham, North Carolina Willamette Valley Cancer Institute, Eugene, Oregon Lehigh Valley Health Network, Allentown, Pennsylvania Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania Local Institution - 0360, Pittsburgh, Pennsylvania St Francis Cancer Center, Greenville, South Carolina Texas Oncology - Central/South Texas, Austin, Texas Texas Oncology - West Texas, El Paso, Texas Texas Oncology - Northeast Texas, Flower Mound, Texas (USOR) Texas Oncology, Houston, Texas Bon Secours St. Francis Medical Center, Midlothian, Virginia Local Institution - 0301, Roanoke, Virginia Shenandoah Oncology, P.C., Winchester, Virginia Argentina
Local Institution - 0011, Ciudad Autónoma de Buenos Aires, Buenos Aires Hospital Italiano de Buenos Aires, ABB, Buenos Aires F.D. Hospital Italiano de Córdoba, Córdoba, Córdoba Province Centro Privado de RMI Río Cuarto S.A. II, Río Cuarto, Córdoba Province Sanatorio Plaza, Rosario, Santa Fe Province Instituto Argentino de Diagnóstico y Tratamiento (IADT), Buenos Aires Centro Oncologico Korben, Buenos Aires Instituto Alexander Fleming, Buenos Aires Local Institution - 0346, Buenos Aires Fundación Oncológica Mendoza, Mendoza Australia
Macquarie University, Macquarie University, New South Wales Royal Brisbane and Women's Hospital, Brisbane, Queensland Grampians Health, Ballarat Central, Victoria Austin Health, Heidelberg, Victoria Peter MacCallum Cancer Centre, Melbourne, Victoria St. John of God Subiaco Hospital, Subiaco, Western Australia Austria
Medizinische Universität Graz, Graz, Styria Medizinische Universitaet Innsbruck, Innsbruck, Tyrol Uniklinikum Salzburg, Salzburg Universitätsklinikum St. Pölten, Sankt Pölten Medizinische Universität Wien, Vienna Brazil
Local Institution - 0187, Manaus, Amazonas Oncocentro Oncologia, Fortaleza, Ceará CEDOES, Vitória, Espírito Santo Centro Integrado de Oncologia de Curitiba, Curitiba, Paraná Futtura Oncology - Clinical Research Hub, Porto Alegre, Rio Grande do Sul Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, São Paulo Local Institution - 0164, São José do Rio Preto, São Paulo Instituto Nacional de Câncer - INCA, Rio de Janeiro Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda, São Paulo Instituto D'Or de Pesquisa e Ensino (IDOR), São Paulo Canada
BC Cancer Kelowna, Kelowna, British Columbia Local Institution - 0217, Victoria, British Columbia The Ottawa Hospital - General Campus, Ottawa, Ontario Centre Hospitalier de l'Université de Montréal, Montreal, Quebec McGill University Health Centre, Montreal, Quebec Centre Intégré de Santé et de Services Sociaux de Lanaudière, Saint-Charles-Borromée, Quebec Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS, Sherbrooke, Quebec Chile
Local Institution - 0138, Santiago, Santiago Metropolitan Local Institution - 0021, Santiago, Santiago Metropolitan Local Institution - 0017, Santiago, Santiago Metropolitan Local Institution - 0018, Santiago, Santiago Metropolitan Local Institution - 0016, Viña del Mar, Valparaiso China
Anhui Provincial Hospital, Hefei, Anhui The Second Hospital of Anhui Medical University, Hefei, Anhui China-Japan Friendship Hospital, Beijing, Beijing Municipality Local Institution - 1005, Beijing, Beijing Municipality Cancer Hospital Chinese Academy of Medical Sciences, Beijing, BEI Local Institution - 1006, Fuzhou, Fujian Fujian Medical University Union Hospital, Fyzhou, Fujian Local Institution - 1016, Xiamen, Fujian Local Institution - 1031, Lanzhou, Gansu Guangxi Medical University Affiliated Cancer Hospital, Nanning, Guangxi Local Institution - 1028, Harbin, Harbin Anyang Cancer Hospital, Anyang, Henan Local Institution - 1009, Zhengzhou, Henan
Colombia
Local Institution - 0195, Medellín, Antioquia Local Institution - 0201, Rionegro, Antioquia Local Institution - 0194, Barranquilla, Atlántico Local Institution - 0182, Puerto Colombia, Atlántico Local Institution - 0181, Montería, COR Local Institution - 0327, Bogota, Cundinamarca Local Institution - 0183, Cali, Valle del Cauca Department Local Institution - 0349, Medellín France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, Aquitaine Local Institution - 0090, Lyon, Auvergne-Rhône-Alpes Local Institution - 0272, Dijon, Côte-d'Or Local Institution - 0098, Toulouse, Haute-Garonne Institut Régional du Cancer Montpellier, Montpellier, Hérault Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer, Rennes, Ille-et-Vilaine Institut de Cancérologie de l'Ouest, Saint-Herblain, Loire-Atlantique Local Institution - 0091, Reims, Marne Gustave Roussy, Villejuif, Paris Institut Paoli-Calmettes, Marseille, Provence-Alpes-Côte d'Azur Region Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne, Clermont-Ferrand, Puy-de-Dôme Local Institution - 1033, Poitiers, Vienne Germany
Klinikum Esslingen, Esslingen am Neckar, Baden-Wurttemberg Klinikum Augsburg, Augsburg, Bavaria Rotkreuzklinikum München gemeinnützige GmbH, München, Bavaria Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt am Main, Hesse Gemeinschaftspraxis für Hämatologie und Onkologie, Langen, Hesse Medizinische Hochschule Hannover, Hanover, Lower Saxony Luisenkrankenhaus Düsseldorf, Düsseldorf, North Rhine-Westphalia Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung, Essen, North Rhine-Westphalia Local Institution - 0254, Leipzig, Saxony Universitätsklinikum Schleswig-Holstein, Lübeck, Schleswig-Holstein Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin, Berlin Vivantes Klinikum Am Urban, Berlin Greece
Local Institution - 0043, Athens, Attikí (Region) Agios Savvas Regional Cancer Hospital, Athens, Attikí Local Institution - 0038, Athens, Attikí University General Hospital of Heraklion, Heraklion, Irakleío India
Local Institution - 0337, Mumbai, Maharashtra Local Institution - 0131, Mumbai, Maharashtra Local Institution - 0134, Nagpur, Maharashtra Local Institution - 0352, New Delhi, National Capital Territory of Delhi Local Institution - 0266, New Delhi, National Capital Territory of Delhi Local Institution - 0206, New Delhi, National Capital Territory of Delhi Local Institution - 0125, Chennai, Tamil Nadu Local Institution - 0130, Hyderabad, Telangana Local Institution - 0133, Varanasi, Uttar Pradesh Israel
Local Institution - 0186, Petah Tikva, Central District Sheba Medical Center, Ramat Gan, Central District Hadassah Medical Center, Jerusalem, Jerusalem Hillel Yaffe Medical Center, Hadera, Northern District Rambam Health Care Campus, Haifa, Northern District Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Campania IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna, Emilia-Romagna Cro-Irccs, Aviano, Friuli Venezia Giulia Ospedale San Martino, Genoa, Liguria Ospedale "Felice Lotti" Di Pontedera, Pontedera, Pisa Nuovo Ospedale di Prato-S.Stefano, Prato, Tuscany Istituto Europeo di Oncologia IRCCS, Milan Azienda Ospedaliera Universitaria Federico II, Naples Azienda Ospedaliero Universitaria Maggiore della Carità, Novara Local Institution - 0056, Padova Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma Japan
Local Institution - 0236, Nagoya, Aichi-ken Local Institution - 0230, Chiba, Chiba Local Institution - 0240, Matsuyama, Ehime Local Institution - 0226, Otashi, Gunma Local Institution - 0222, Sapporo, Hokkaido Local Institution - 0232, Kanazawa, Ishikawa-ken Local Institution - 0234, Isehara, Kanagawa Local Institution - 0237, Yokohama, Kanagawa Local Institution - 0246, Tsu, Mie-ken Local Institution - 0223, Sendai, Miyagi Local Institution - 0238, Suita, Osaka Local Institution - 0227, Hidaka, Saitama Local Institution - 0224, Ina-machi, Saitama Mexico
Local Institution - 0177, Mexico City, DIF Local Institution - 0264, Tijuana, Estado de Baja California Local Institution - 0178, Guadalajara, Jalisco Local Institution - 0329, Mexico City, Mexico City Local Institution - 0175, Monterrey, Nuevo León Local Institution - 0176, Monterrey, Nuevo León Local Institution - 0355, Monterrey, Nuevo León Local Institution - 0173, Oaxaca City, Oaxaca Local Institution - 0179, Mérida, Yucatán Local Institution - 0174, Chihuahua City Poland
AIDPORT Sp. z o.o., Skórzewo, Greater Poland Voivodeship Local Institution - 0074, Biała Podlaska, Lublin Voivodeship Local Institution - 0072, Warsaw, Masovian Voivodeship Mazowiecki Szpital Onkologiczny, Warsaw, Masovian Voivodeship Local Institution - 0076, Opole, Opole Voivodeship Local Institution - 0221, Lodz, Łódź Voivodeship Portugal
Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Lisbon District Local Institution - 0106, Lisbon, Lisbon District Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon, Lisbon District Instituto Portugês de Oncologia de Coimbra Francisco Gentil, Coimbra Hospital da Luz Lisboa, Lisbon Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto Centro Hospitalar de Sao Joao - Hospital de Sao Joao, Porto Romania
Local Institution - 0212, Bistriţa, Bistrița-Năsăud County Local Institution - 0213, Bucharest, Bucharest SC Radiotherapy Center Cluj SRL, Florești, Cluj Centrul de Oncologie "Sfântul Nectarie", Craiova, Dolj Cabinet Medical Oncomed, Timișoara, Timiș County Spitalul Clinic Filantropia, Bucharest Institutul Oncologic Cluj, Cluj-Napoca Centrul de Radioterapie Amethyst Timis, Dumbrăviţa S.C. Centrul de Oncologie Euroclinic S.R.L., Iași Institutul Regional de Oncologie, Iași Spitalul Municipal Schuller Ploiești, Ploieşti South Africa
Local Institution - 0351, East London, Eastern Cape Local Institution - 0342, Parktown, Gauteng Local Institution - 0336, Pretoria, Gauteng Local Institution - 0341, Pretoria, Gauteng Local Institution - 0340, Soweto, Gauteng Local Institution - 1034, Panorama, Western Cape South Korea
Local Institution - 0066, Goyang-si, Kyǒnggi-do Local Institution - 0067, Seongnam, Kyǒnggi-do Local Institution - 0068, Seoul, Seoul-teukbyeolsi [Seoul] Local Institution - 0063, Seoul, Seoul-teukbyeolsi [Seoul] Local Institution - 0071, Seoul, Seoul-teukbyeolsi [Seoul] Local Institution - 0064, Seoul, Seoul-teukbyeolsi [Seoul] Local Institution - 0065, Seoul, Seoul-teukbyeolsi [Seoul] Local Institution - 0069, Daegu, Taegu-Kwangyǒkshi Spain
CHUAC-Hospital Teresa Herrera, A Coruña, A Coruña [La Coruña] Hospital General Universitario de Elche, Elche, Alicante Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona] Local Institution - 0172, Hospitalet, Barcelona [Barcelona] Hospital Clínic de Barcelona, Barcelona, Catalunya [Cataluña] Hospital Universitario Donostia, Donostia / San Sebastian, Gipuzkoa Hospital General Universitario Gregorio Marañon, Madrid, Madrid, Comunidad de Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad de Hospital Universitario Virgen de la Victoria, Málaga, Málaga Hospital Clinico de Valencia, Valencia, Valenciana, Comunitat Hospital Beata María Ana, Madrid Hospital Universitario Virgen Macarena, Seville Sweden
Skånes Universitetssjukhus Malmö, Malmo, Skåne Län [se-12] Capio Saint Görans Sjukhus, Stockholm, Stockholms Län [se-01] Akademiska sjukhuset, Uppsala, Uppsala Län [se-03] Universitetssjukhuset Örebro, Örebro, Örebro Län [se-18] Universitetssjukhuset i Linköping, Linköping, Östergötlands Län [se-05] Switzerland
Cantonal Hospital St.Gallen, Sankt Gallen, Canton of St. Gallen CHUV (centre hospitalier universitaire vaudois), Lausanne, Canton of Vaud Turkey (Türkiye)
Local Institution - 0361, Adana Local Institution - 0362, Ankara Local Institution - 0364, Istanbul Local Institution - 0363, Istanbul United Arab Emirates
Local Institution - 0323, Abu Dhabi, Abu Dhabi Emirate Local Institution - 0318, Abu Dhabi, Abu Dhabi Emirate Local Institution - 0322, Al Ain City, Abu Dhabi Emirate Local Institution - 0319, Abu Dhabi United Kingdom
The Royal Cornwall Hospital, Truro, England St Bartholomew's Hospital, London, London, City of Guy's & St Thomas' NHS Foundation Trust, London, London, City of Local Institution - 0204, London, London, City of Local Institution - 0171, Belfast The Christie NHS Foundation Trust, Manchester Local Institution - 0006, Nottingham
Key details Phase
Safety & dosing / Large-scale testing
Sponsor
Bristol-Myers Squibb
Collaborators
SystImmune Inc.
Enrollment target
~500 participants
Primary completion
March 2028
Local Institution - 1032, Zhengzhou, Henan
Zhongnan Hospital of Wuhan University, Wuhan, Hubei Hubei Cancer Hospital, Wuhan, Hubei Xiangyang Central Hospital, Xiangyang, Hubei Local Institution - 1011, Changsha, HUN Jiangxi Cancer Hospital, Nanchang, Jiangxi Local Institution - 1012, Changchun, Liaoning Local Institution - 1014, Shenyang, Liaoning Local Institution - 1017, Jinan, Shandong Local Institution - 1015, Qingdao, Shandong Local Institution - 1018, Taiyuan, Shanxi Sichuan Provincial People'S Hospital, Chengdu, Sichuan Tianjin Cancer Hospital Airport Hospital, Tianjin, Tianjin Municipality Local Institution - 1020, Tianjin, Tianjin Municipality Local Institution - 1029, Kunming, Yunnan Local Institution - 1023, Hangzhou, Zhejiang Local Institution - 1025, Guangzhou Centre Oscar Lambret, Lille
Local Institution - 0088, Paris Gynaekologisches Zentrum Bonn, Bonn
Universitaetsklinikum Carl Gustav Carus Dresden, Dresden Universitaetsklinikum Heidelberg, Heidelberg Universitaetsklinikum Ulm, Ulm Local Institution - 0231, Bunkyo-ku, Tokyo
Local Institution - 0229, Chuo-ku, Tokyo Local Institution - 0228, Koto, Tokyo Local Institution - 0245, Shinagawa, Tokyo Local Institution - 0233, Shinjuku-ku, Tokyo Local Institution - 0242, Fukuoka Local Institution - 0225, Fukushima Local Institution - 0243, Hiroshima Local Institution - 0244, Kagoshima Local Institution - 0235, Kyoto Local Institution - 0241, Okayama Local Institution - 0239, Osaka