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

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Unknown Primary	NCT ID:	NCT05253651
Trial Phases:	Phase III	Protocol IDs:	SGNTUC-029 (primary) NCI-2022-07692 2021-002672-40
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Seagen Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05253651

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 test 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.