450
Participants
Start Date
May 3, 2024
Primary Completion Date
January 4, 2027
Study Completion Date
May 6, 2027
Sacituzumab tirumotecan
Participants will receive sacituzumab tirumotecan as 4mg/kg IV infusion on days 1, 15, and 29 of every 42-day cycle.
Trifluridine-Tipiracil
Trifluridine-tipiracil will be administered at 35 mg/m\^2 as tablet orally twice a day on days 1-5 and 8-12 of every 28-day cycle.
Irinotecan
Irinotecan will be administered at a dose of 150 mg/m\^2 by IV infusion on days 1 and 15 of every 28-day cycle.
Paclitaxel
Paclitaxel will be administered at a dose of 80 mg/m\^2 by IV infusion on days 1, 8 and 15 of every 28-day cycle.
Docetaxel
Docetaxel will be administered at a dose of 75 mg/m\^2 by IV infusion on day 1 of a 21-day cycle.
Rescue medication
Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
RECRUITING
Taipei Veterans General Hospital ( Site 3601), Taipei
RECRUITING
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3604), Tainan City
RECRUITING
Institut Jules Bordet-GastroIntestinal Medical Oncology ( Site 1003), Anderlecht
RECRUITING
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001), Brussels
RECRUITING
Rigshospitalet ( Site 1102), Copenhagen
RECRUITING
UZ Leuven-Digestive Oncology ( Site 1000), Leuven
RECRUITING
Odense Universitetshospital-Department of oncology ( Site 1101), Odense
RECRUITING
AZ Delta vzw ( Site 1002), Roeselare
RECRUITING
Aalborg Universitetshospital, Syd-Department of Oncology ( Site 1103), Aalborg
RECRUITING
National Taiwan University Hospital ( Site 3600), Taipei
RECRUITING
Chulalongkorn University ( Site 3702), Bangkok
RECRUITING
Hospital Pulau Pinang ( Site 3403), George Town
RECRUITING
Faculty of Medicine Siriraj Hospital ( Site 3700), Bangkok
RECRUITING
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0904), Concepción
RECRUITING
Hospital de Alta Complejidad La Libertad-Unidad de Investigación en Oncología ( Site 0902), Trujillo
RECRUITING
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 1304), Berlin
RECRUITING
Seoul National University Bundang Hospital ( Site 3504), Seongnam
RECRUITING
Clínicas AUNA Sede Chiclayo ( Site 0907), Chiclayo
RECRUITING
Centre François Baclesse ( Site 1202), Caen
RECRUITING
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1905), A Coruña
RECRUITING
Clínica Internacional - Sede San Borja ( Site 0906), Lima
RECRUITING
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 0905), Lima
RECRUITING
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 0900), Lima
RECRUITING
UPMC Hillman Cancer Center ( Site 0126), Pittsburgh
RECRUITING
Ospedale San Raffaele-Oncologia Medica ( Site 1701), Milan
RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1700), Milan
RECRUITING
Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 1300), Hamburg
RECRUITING
Dicle Üniversitesi-oncology ( Site 2108), Diyarbakır
RECRUITING
Inova Schar Cancer ( Site 0106), Fairfax
RECRUITING
Städtisches Krankenhaus Kiel-2. Medizinische Klinik ( Site 1306), Kiel
RECRUITING
Atatürk Üniversitesi-onkoloji ( Site 2111), Erzurum
RECRUITING
Hospital Clinico San Carlos ( Site 1903), Madrid
RECRUITING
MUSC Hollings Cancer Center-Hematology Oncology ( Site 0122), Charleston
COMPLETED
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0108), Marietta
RECRUITING
COMPLEJO HOSPITALARIO DE NAVARRA-Medical Oncology ( Site 1904), Pamplona
RECRUITING
CHU Rangueil-Digestive oncology department ( Site 1210), Toulouse
RECRUITING
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0129), Orlando
RECRUITING
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1902), Oviedo
RECRUITING
Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1211), Bordeaux
RECRUITING
Chang Gung Medical Foundation-Linkou Branch ( Site 3602), Taoyuan District
RECRUITING
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2106), Istanbul
RECRUITING
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1203), Rennes
RECRUITING
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1310), Göttingen
RECRUITING
The West Clinic, PLLC dba West Cancer Center ( Site 0110), Germantown
RECRUITING
Hospital Universitario Marqués de Valdecilla ( Site 1901), Santander
RECRUITING
The University of Louisville, James Graham Brown Cancer Center-James Graham Brown Cancer Center ( Site 0113), Louisville
RECRUITING
Norton Audubon Hospital-Norton Cancer Institute - Audubon ( Site 0105), Louisville
RECRUITING
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0124), Lexington
RECRUITING
CANCER TREAMTENT CLINIC AND CLINICAL TRIALS SA DE CV ( Site 0814), Guadalajara
RECRUITING
Henry Ford Hospital ( Site 0107), Detroit
RECRUITING
University Malaya Medical Centre-Clinical Oncology ( Site 3402), Kuala Lumpur
RECRUITING
Samsun Medical Park Hastanesi-medical oncology ( Site 2110), Samsun
RECRUITING
Azienda Ospedaliero Universitaria Pisana ( Site 1702), Pisa
RECRUITING
Sanford Cancer Center ( Site 0136), Sioux Falls
RECRUITING
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0138), Fargo
RECRUITING
Centre Oscar Lambret ( Site 1206), Lille
RECRUITING
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 3408), Kuala Lumpur
RECRUITING
University of Chicago Medical Center ( Site 0120), Chicago
RECRUITING
National Cancer Institute-Radiotherapy and Oncology ( Site 3404), Putrajaya
RECRUITING
Sourasky Medical Center ( Site 1602), Tel Aviv
RECRUITING
Yuzuncu Yil University Dursun Odaba Tp Merkezi-Medical Oncology ( Site 2109), Van
RECRUITING
Centro de Investigacion Clinica de Oaxaca ( Site 0810), Oaxaca City
RECRUITING
CENTRE LEON BERARD-Medical oncology ( Site 1208), Lyon
RECRUITING
NCT-Department of Medical Oncology ( Site 1302), Heidelberg
RECRUITING
Institut Mutualiste Montsouris-Oncology ( Site 1216), Paris
RECRUITING
Hôpital Saint-Louis ( Site 1201), Paris
RECRUITING
Centro Potosino de Investigación Médica ( Site 0801), San Luis Potosí City
RECRUITING
"Azienda Ospedaliera Universitaria dell'Università Luigi Van-UOC Oncoematologia ( Site 1704)", Napoli
RECRUITING
Banner MD Anderson Cancer Center ( Site 0119), Gilbert
RECRUITING
Centre Hospitalier Universitaire de Poitiers ( Site 1209), Poitiers
RECRUITING
Songklanagarind hospital ( Site 3701), Hat Yai
RECRUITING
UCLA Hematology/Oncology - Santa Monica ( Site 0140), Los Angeles
RECRUITING
Sarawak General Hospital-Radiotherapy Unit ( Site 3401), Kuching
RECRUITING
Oregon Health and Science University ( Site 0104), Portland
RECRUITING
Fred Hutchinson Cancer Center ( Site 0111), Seattle
RECRUITING
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0602), Bogotá
RECRUITING
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603), Bogotá
RECRUITING
Jilin Province Tumor Hospital ( Site 3018), Changchun
RECRUITING
Harbin Medical University Cancer Hospital-Harbin Medical University Cancer Hospital ( Site 3005), Harbin
RECRUITING
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0600), Valledupar
RECRUITING
Fudan University Shanghai Cancer Center-medical oncology ( Site 3009), Shanghai
RECRUITING
Zhongshan Hospital,Fudan University-Oncology ( Site 3003), Shanghai
RECRUITING
Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3042), Shanghai
RECRUITING
The First Affiliated Hospital of Soochow University ( Site 3040), Suzhou
RECRUITING
Anhui Provincial Cancer Hospital-medical oncology ( Site 3016), Hefei
RECRUITING
Second Affiliated hospital of Anhui Medical University-Oncology ( Site 3038), Hefei
RECRUITING
LinYi Cancer Hospital-Gastrology department ( Site 3024), Linyi
RECRUITING
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Oncology ( Site 3006), Hangzhou
RECRUITING
Zhejiang Cancer Hospital-Oncology ( Site 3021), Hangzhou
RECRUITING
Taizhou Hospital of Zhejiang Province ( Site 3020), Linhai
RECRUITING
Yueqing People's Hospital ( Site 3041), Yueqing
RECRUITING
The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3037), Nanchang
RECRUITING
Fujian Cancer Hospital ( Site 3007), Fuzhou
RECRUITING
The 900th Hospital of the Joint Logistics Support Force of PLA ( Site 3008), Fuzhou
RECRUITING
The First Affiliated hospital of Xiamen University-oncology ( Site 3011), Xiamen
RECRUITING
Zhongshan Hospital Affiliated to Xiamen University ( Site 3013), Xiamen
RECRUITING
Chongqing University Three Gorges Hospital ( Site 3036), Chongqing
RECRUITING
China Medical University Hospital ( Site 3603), Taichung
RECRUITING
Hunan Cancer Hospital ( Site 3014), Changsha
RECRUITING
Hubei Cancer Hospital ( Site 3012), Wuhan
RECRUITING
Xiangyang Central Hospital ( Site 3045), Xiangyang
RECRUITING
Henan Cancer Hospital-henan cancer hospital ( Site 3002), Zhengzhou
RECRUITING
Southern Medical University Nanfang Hospital-Department of Oncology ( Site 3019), Guangzhou
RECRUITING
Sun Yatsen University Cancer Center ( Site 3001), Guangzhou
RECRUITING
Cancer Hospital of Shantou University Medical College ( Site 3034), Shantou
RECRUITING
Affiliated Cancer Hospital of Guangxi Medical University ( Site 3047), Nanning
RECRUITING
West China Hospital, Sichuan University ( Site 3035), Chengdu
RECRUITING
Sichuan Cancer hospital. ( Site 3030), Chengdu
RECRUITING
Beijing Anzhen Nanchong Hospital of Capital Medical University (Nanchong Central Hospital) ( Site 3029), Nanchong
RECRUITING
Yunnan Province Cancer Hospital ( Site 3031), Kunming
RECRUITING
Fundación Valle del Lili-Fundacion Valle del Lili ( Site 0607), Santiago de Cali
RECRUITING
Xinjiang Medical University Cancer Hospital - Urumchi-The No.11 of Surgery building ( Site 3010), Ürümqi
RECRUITING
Queen Elizabeth Hospital ( Site 3101), Yau Ma Tei
RECRUITING
Rambam Health Care Campus-Oncology Division ( Site 1600), Haifa
RECRUITING
Hillel Yaffe Medical Center ( Site 1604), Hadera
RECRUITING
James Lind Centro de Investigacion del Cancer ( Site 0506), Temuco
RECRUITING
Rabin Medical Center ( Site 1605), Petah Tikva
RECRUITING
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0503), Santiago
RECRUITING
FALP-UIDO ( Site 0500), Santiago
RECRUITING
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 0502), Santiago
RECRUITING
Bradfordhill-Clinical Area ( Site 0501), Santiago
RECRUITING
Hadassah Medical Center ( Site 1603), Jerusalem
RECRUITING
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0411), São José do Rio Preto
RECRUITING
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará ( Site 0405), Fortaleza
RECRUITING
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0406), Natal
RECRUITING
Hospital de Caridade de Ijuí ( Site 0412), Ijuí
RECRUITING
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0400), Porto Alegre
RECRUITING
Centro de Hematologia e Oncologia ( Site 0404), Joinville
ACTIVE_NOT_RECRUITING
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0401), Barretos
RECRUITING
A. C. Camargo Cancer Center ( Site 0409), São Paulo
RECRUITING
IBCC - Núcleo de Pesquisa e Ensino ( Site 0402), São Paulo
RECRUITING
McGill University Health Centre ( Site 0201), Montreal
RECRUITING
Fourth Hospital of Hebei Medical University ( Site 3015), Shijiazhuang
RECRUITING
Centro Cancerológico del Caribe (CECAC) ( Site 0606), Barranquilla
RECRUITING
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 1307), Dresden
RECRUITING
Queen Mary Hospital ( Site 3100), Hong Kong
RECRUITING
Prince of Wales Hospital ( Site 3102), Shatin
RECRUITING
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1703), Rome
ACTIVE_NOT_RECRUITING
Aichi Cancer Center ( Site 3307), Nagoya
ACTIVE_NOT_RECRUITING
National Cancer Center Hospital East ( Site 3300), Kashiwa
ACTIVE_NOT_RECRUITING
Kochi Medical School Hospital ( Site 3304), Nankoku
ACTIVE_NOT_RECRUITING
Saitama Prefectural Cancer Center ( Site 3302), Kita-Adachi
ACTIVE_NOT_RECRUITING
National Cancer Center Hospital ( Site 3301), Chūō
ACTIVE_NOT_RECRUITING
Cancer Institute Hospital of JFCR ( Site 3306), Koto
COMPLETED
National Hospital Organization Kyushu Cancer Center ( Site 3303), Fukuoka
ACTIVE_NOT_RECRUITING
Osaka International Cancer Institute ( Site 3305), Osaka
RECRUITING
COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 0802), Mexico City
RECRUITING
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1807), Bydgoszcz
RECRUITING
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site 1800), Warsaw
RECRUITING
Bialostockie Centrum Onkologii ( Site 1804), Bialystok
RECRUITING
"Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej Profil Jednego Dnia ( Site 1810)", Gdynia
RECRUITING
Szpital Wojewódzki w Koszalinie. ( Site 1801), Poland
RECRUITING
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 1811), Kielce
RECRUITING
Seoul National University Hospital-Oncology ( Site 3503), Seoul
RECRUITING
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3500), Seoul
RECRUITING
Asan Medical Center-Department of Oncology ( Site 3501), Seoul
RECRUITING
Samsung Medical Center-Division of Hematology/Oncology ( Site 3502), Seoul
RECRUITING
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3505), Seoul
RECRUITING
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1900), Barcelona
RECRUITING
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2104), Adana
RECRUITING
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100), Ankara
RECRUITING
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101), Ankara
RECRUITING
Addenbrooke's Hospital ( Site 2203), Cambridge
RECRUITING
Ninewells Hospital and Medical School-Oncology Petty ( Site 2209), Dundee
RECRUITING
St Bartholomew's Hospital ( Site 2206), London
RECRUITING
The Christie NHS Foundation Trust-Medical Oncology ( Site 2201), Manchester
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INDUSTRY