Spots Global Cancer Trial Database for A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer
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Trial Identification
Brief Title: A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer
Official Title: A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)
Study ID: NCT04479436
Conditions
Interventions
Study Description
Brief Summary: This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.
Detailed Description: There will be 2 cohorts with enrollment in 2 parts. Participants will be treated on Day 1 of each 21-day cycle (every 3 weeks) with U3-1402 5.6 mg/kg intravenous (IV). The estimated treatment period is approximately 8 months and the follow-up period is approximately 4 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology, Fayetteville, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern Medical Faculty Foundation NMFF Hematology Oncology, Chicago, Illinois, United States
John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
West Cancer Center, Germantown, Tennessee, United States
Sarah Cannon, Nashville, Tennessee, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center University of Texas, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Virgina Cancer Specialists, Fairfax, Virginia, United States
UZ Antwerpen, Edegem, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Georges-Franois Leclerc, Dijon, , France
CHU Nantes, Nantes, , France
Hospital St Antoine, Paris, , France
Asst Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Aichi Cancer Center Hospital, Nagoya-shi, Nagoya-shi, Aichi-ken, Japan
National Hospital Organization - Osaka National Hospital (ONH), Osaka-shi, Osaka-shi, Osaka-fu, Japan
Kindai University Hospital, Osaka, Osakasayama Shi, Japan
National Cancer Center Hospital East, Chiba, , Japan
The Cancer Institute Hospital Of JFCR, Tokyo, , Japan
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Ostrów Wielkopolski, Poznan, Poland
Szpital Kliniczny Przemienienia Pańskiego.University Hospital, Chemotherapy Department, Poznań, , Poland
M Sklodowska Curie Memorial Cancer Center, Warszawa, , Poland
M Sklodowska Curie Memorial Cancer Center, Warszawa, , Poland
Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques IMIM, Barcelona, , Spain
VHIO Valle de Hebron Instituto de Oncologia, Barcelona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, CIOCC, Madrid, , Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell, Sabadell, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Royal Marsden Hospital NHS, London, , United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
Royal Marsden Hospital NHS, London, , United Kingdom
Sarah Cannon, London, , United Kingdom
Contact Details
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR
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