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

Exploring new treatment options for HER2+ metastatic colorectal cancer.

Recruiting
18 years and older
All
Phase 3

This study is testing new cancer drugs for people with a special type of colorectal cancer called HER2 positive that has spread (metastatic) or can't be removed by surgery (unresectable). The study compares a drug called tucatinib, along with trastuzumab and mFOLFOX6, against the usual treatment. HER2 positive means the cancer cells have more of a protein that helps them grow. mFOLFOX6 is a mix of drugs often used for this cancer. The study checks if tucatinib works better and what side effects, or extra problems caused by the drugs, might happen.

Participants are randomly placed in one of two groups: one gets tucatinib with other drugs, and the other gets standard treatments like mFOLFOX6 alone or with bevacizumab or cetuximab. To join, participants must have a type of colorectal cancer confirmed by tests, have the HER2+ disease, and have measurable disease areas.

  • The study involves taking new drugs, which might help more than current treatments.
  • Participants are randomly assigned to either the new drug group or the usual treatment group.
  • Participants need to meet specific health criteria to join the study.
Study details
    Colorectal Neoplasms

NCT05253651

Seagen, a wholly owned subsidiary of Pfizer

29 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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