Study Comparing Tucatinib with Trastuzumab and mFOLFOX6 to Standard Treatment for First-line HER2+ Metastatic Colorectal Cancer

Sponsor: Seagen Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05253651

Provider View

This clinical trial is testing whether a new combination of cancer drugs, including tucatinib, works better than the usual treatments for patients with HER2 positive colorectal cancer that has spread or cannot be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to see if a new combination of drugs—tucatinib, trastuzumab, and mFOLFOX6—can treat HER2 positive colorectal cancer more effectively than the standard treatments. The study will also look at what side effects occur with this new combination. Participants have colorectal cancer that has spread (metastatic) or cannot be removed by surgery (unresectable). Participants will be randomly assigned to receive either the new drug combination or the standard treatment, which could be mFOLFOX6 alone, mFOLFOX6 with bevacizumab, or mFOLFOX6 with cetuximab. All drugs used in this study are already used to treat this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of adenocarcinoma of the colon or rectum that is advanced and cannot be removed by surgery or has spread to other parts of the body.
  • Able to provide a recent tumor sample for testing before starting the study treatment.
  • Have HER2 positive cancer as confirmed by a specific test.
  • Have a specific type of cancer gene called RAS wild-type, confirmed by testing.
  • Have at least one measurable tumor that has not been treated with radiation, or if it has been treated, it must show signs of growth since the treatment.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • May have no brain metastases or previously treated brain metastases that are not causing symptoms.

Exclusion Criteria

  • Have not received any prior systemic cancer treatment for advanced or metastatic colorectal cancer, except for up to 2 doses of mFOLFOX6 before joining the study.
  • Have not had radiation therapy within 14 days before joining the study (or within 7 days if it was stereotactic radiosurgery).
  • Have not been treated with anti-HER2 therapy before.
  • Do not have ongoing severe nerve damage (neuropathy).
  • Do not have an active or untreated hole in the gastrointestinal tract at the time of screening.

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