A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
NCT05253651
This study is recruiting at 108 US sites in 17 states, according to its ClinicalTrials.gov record last updated .
Summary
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Colorectal Neoplasms
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Last updated on ClinicalTrials.gov
- July 22, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 4
- Palo Verde Hematology Oncology · Glendale, AZ
- Mayo Clinic Building - Phoenix · Phoenix, AZ
- Mayo Clinic Hospital · Phoenix, AZ
- Mayo Clinic · Scottsdale, AZ
California · 8
- Los Angeles Cancer Network - Anaheim · Anaheim, CA
- Los Angeles Cancer Network - Fountain Vally · Fountain Valley, CA
- Los Angeles Cancer Network - Corporate Office · Glendale, CA
- Los Angeles Hematology Oncology Medical Group · Glendale, CA
- Los Angeles Hematology Oncology Medical Group · Glendale, CA
- Los Angeles Hematology Oncology Medical Group · Los Angeles, CA
- Los Angeles Hematology Oncology Medical Group · Pasadena, CA
- Los Angeles Hematology Oncology Medical Group · Van Nuys, CA
Colorado · 11
- Rocky Mountain Cancer Centers, LLP · Aurora, CO
- Rocky Mountain Cancer Centers, LLP · Boulder, CO
- Rocky Mountain Cancer Centers, LLP · Colorado Springs, CO
- Rocky Mountain Cancer Centers, LLP · Denver, CO
- Rocky Mountain Cancer Centers, LLP · Denver, CO
- Rocky Mountain Cancer Centers, LLP · Lakewood, CO
- Rocky Mountain Cancer Centers, LLP · Littleton, CO
- Rocky Mountain Cancer Centers, LLP · Lone Tree, CO
- Rocky Mountain Cancer Centers, LLP · Longmont, CO
- Rocky Mountain Cancer Centers, LLP · Pueblo, CO
- Rocky Mountain Cancer Centers, LLP · Thornton, CO
Florida · 3
- Mount Sinai Medical Center Aventura ER · Aventura, FL
- Mount Sinai Comprehensive Cancer Center · Miami Beach, FL
- Mount Sinai Medical Center · Miami Beach, FL
Georgia · 4
- Emory Saint Joseph's Hospital · Atlanta, GA
- Emory University Hospital · Atlanta, GA
- Emory University Hospital Midtown · Atlanta, GA
- Winship Cancer Institute · Atlanta, GA
Kentucky · 7
- Norton Audubon Hospital · Louisville, KY
- Norton Brownsboro Hospital · Louisville, KY
- Norton Cancer Institute - Downtown · Louisville, KY
- Norton Cancer Institute, Audubon Hospital Campus · Louisville, KY
- Norton Cancer Institute, Brownsboro Hospital Campus · Louisville, KY
- Norton Cancer Institute, Downtown · Louisville, KY
- Norton Hospital · Louisville, KY
Minnesota · 20
- Minnesota Oncology Hematology, PA · Burnsville, MN
- Allina Health Cancer institute · Coon Rapids, MN
- Minnesota Oncology Hematology, PA · Coon Rapids, MN
- M Health Fairview Cancer Clinic-Edina · Edina, MN
- Minnesota Oncology Hematology, PA · Edina, MN
- Minnesota Oncology Hematology, PA · Fridley, MN
- Minnesota Oncology Hematology, PA · Maple Grove, MN
- M Health Fairview St. John's Hospital · Maplewood, MN
- Minnesota Oncology Hematology, PA · Maplewood, MN
- Allina Health Cancer Institute (Virginia Piper Cancer Institute) · Minneapolis, MN
- Hennepin County Medical Center · Minneapolis, MN
- Minnesota Oncology Hematology, PA · Minneapolis, MN
- North Memorial Health Cancer Center · Robbinsdale, MN
- Mayo Clinic Cancer Center Outpatient Pharmacy · Rochester, MN
- Metro Minnesota Community Oncology Research Consortium · Saint Louis Park, MN
- Park Nicollet Frauenshuh Cancer Center · Saint Louis Park, MN
- Regulatory Location: MMCORC · Saint Louis Park, MN
- Allina Health Cancer Institute-United(VPCI) · Saint Paul, MN
- Regions Hospital · Saint Paul, MN
- Minnesota Oncology Hematology, PA Cornerstone Medical Specialty Center · Woodbury, MN
New Jersey · 3
- MSK Basking Ridge · Basking Ridge, NJ
- MSK Monmouth · Middletown, NJ
- MSK Bergen · Montvale, NJ
New York · 5
- MSK Commack · Commack, NY
- MSK Westchester · Harrison, NY
- Memorial Solan Kettering Cancer Center- Main Campus · New York, NY
- Rockefeller Outpatient Pavilion (53rd Street) · New York, NY
- MSK Nassau · Uniondale, NY
North Carolina · 5
- Duke University Hospital · Durham, NC
- Duke University Medical Center · Durham, NC
- Duke University Medical Center, Duke Cancer Center · Durham, NC
- FirstHealth Cancer Center · Pinehurst, NC
- FirstHealth Moore Regional Hospital · Pinehurst, NC
Oregon · 11
- Northwest Cancer Specialists, P.C · Happy Valley, OR
- Providence Cancer Institute Newberg Clinic · Newberg, OR
- Providence Cancer Institute Willamette Falls Clinic · Oregon City, OR
- Northwest Cancer Specialists, P.C. · Portland, OR
- Providence Cancer Institute Franz Clinic · Portland, OR
- Providence Oncology and Hematology Care Clinic - Westside · Portland, OR
- Providence Portland Medical Center · Portland, OR
- Providence Portland Medical Center-Westside · Portland, OR
- Providence St. Vincent Medical Center · Portland, OR
- Providence St. Vincent Medical Center- Investigational Drug Services · Portland, OR
- Northwest Cancer Specialists, P.C. · Tigard, OR
Pennsylvania · 13
- UPMC Hillman Cancer Center - Beaver · Beaver, PA
- UPMC Hillman Cancer Center at Butler Health System · Butler, PA
- UPMC Hillman Cancer Center Erie · Erie, PA
- UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health · Greensburg, PA
- UPMC Hillman Cancer Center - Pinnacle (Community Osteopathic / Medical Sciences Pavillion) · Harrisburg, PA
- UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health · Irwin, PA
- UPMC Hillman Cancer Center - Pinnacle (Ortenzio) · Mechanicsburg, PA
- UPMC Hillman Cancer Center - Monroeville · Monroeville, PA
- St. Clair Cancer Center Medical Oncology · Pittsburgh, PA
- UPMC Hillman Cancer Center · Pittsburgh, PA
- UPMC Hillman Cancer Center - Passavant (HOA) · Pittsburgh, PA
- UPMC Hillman Cancer Center - St Margarets · Pittsburgh, PA
- UPMC Hillman Cancer Center - Washington · Washington, PA
South Dakota · 1
- Avera Cancer Institute · Sioux Falls, SD
Tennessee · 1
- Henry-Joyce Cancer Clinic · Nashville, TN
Texas · 4
- Texas Oncology - DFW · Dallas, TX
- The University of Texas MD Anderson Cancer Center · Houston, TX
- US Oncology Investigational Product Center (IPC) · Irving, TX
- US Oncology Investigational Products Center (IPC) · Irving, TX
Virginia · 5
- Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care · Blacksburg, VA
- Oncology & Hematology Associates of Southwest Virginia · Low Moor, VA
- Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care · Roanoke, VA
- Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care · Salem, VA
- Oncology & Hematology Associates of Southwest Virginia · Wytheville, VA
Washington · 3
- Providence Regional Cancer Partnership · Everett, WA
- Providence Regional Medical Center Everett · Everett, WA
- Northwest Cancer Specialists, P.C. · Vancouver, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.