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Study identifier: NCT05253651 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Condition: Colorectal Neoplasms  ·  Sponsor: Seagen, a wholly owned subsidiary of Pfizer

PhasePhase 3
Planned participants400
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

This description comes directly from the study's public registry record.

Talk to the study team

Pfizer CT.gov Call Center  ·  1-800-718-1021  ·  ClinicalTrials.gov_Inquiries@pfizer.com

Always discuss trial participation with your own doctor first.

Locations (366)

Palo Verde Hematology OncologyGlendale, Arizona, United StatesRecruiting
Mayo Clinic Building - PhoenixPhoenix, Arizona, United StatesRecruiting
Mayo Clinic HospitalPhoenix, Arizona, United StatesRecruiting
Mayo ClinicScottsdale, Arizona, United StatesRecruiting
Los Angeles Cancer Network - AnaheimAnaheim, California, United StatesRecruiting
Kaiser Permanente Anaheim Kraemer Medical OfficesAnaheim, California, United StatesActive Not Recruiting
Kaiser Permanente Baldwin Park Medical CenterBaldwin Park, California, United StatesActive Not Recruiting
Kaiser Permanente Bellflower Medical OfficesBellflower, California, United StatesActive Not Recruiting
Kaiser Permanente Fontana Medical CenterFontana, California, United StatesActive Not Recruiting
Los Angeles Cancer Network - Fountain VallyFountain Valley, California, United StatesRecruiting
Los Angeles Cancer Network - Corporate OfficeGlendale, California, United StatesRecruiting
Los Angeles Hematology Oncology Medical GroupGlendale, California, United StatesRecruiting

+ 354 more locations — full list on the registry record.

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