40
Participants
Start Date
September 15, 2020
Primary Completion Date
July 31, 2024
Study Completion Date
September 30, 2025
tucatinib
For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
trastuzumab
Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
oxaliplatin
85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.
leucovorin
200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.
fluorouracil
400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
capecitabine
1000 mg/m\^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
pembrolizumab
400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
Sibley Memorial Hospital, Washington D.C.
Duke University Medical Center, Duke Cancer Center, Durham
Duke University Medical Center, Durham
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy, Cleveland
Cleveland Clinic, Cleveland
Siteman Cancer Center - North County, Florissant
Siteman Cancer Center, St Louis
Barnes-Jewish Hospital, St Louis
Washington University School of Medicine, St Louis
Siteman Cancer Center - South County, St Louis
Siteman Cancer Center - West County, Creve Coeur
Siteman Cancer Center - St Peters, City of Saint Peters
University of Colorado Denver CTO(CTRC), Aurora
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP), Aurora
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP), Aurora
PCM Trials, Denver
Mayo Clinic Hospital, Phoenix
Mayo Clinic, Scottsdale
University of New Mexico Comprehensive Cancer Center, Albuquerque
Fred Hutchinson Cancer Center, Seattle
University of Washington Medical Center, Seattle
Aichi Cancer Center Hospital, Nagoya
National Cancer Center Hospital East, Kashiwa-shi
St. Marianna University Hospital, Kawasaki
Osaka International Cancer Institute, Osaka
National Cancer Center Hospital, Chuo-ku
Cancer Institute Hospital of Japanese Foundation for Cancer Research., Koto-ku
Seagen, a wholly owned subsidiary of Pfizer
INDUSTRY