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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: tucatinib (drug), trastuzumab (drug), bevacizumab (drug), cetuximab (drug)
How long the study runs: Study runs about 93 months (dates as stated)
About the drug or intervention: tucatinib — drug: 300mg given by mouth (orally) twice daily · trastuzumab — drug: 8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter. · bevacizumab — drug: 5mg/kg given by IV every 2 weeks · cetuximab — drug: 400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly · oxaliplatin — drug: 85mg/m2 given by IV every 2 weeks. · leucovorin — drug: 400mg/ m2 given by IV every 2 weeks. · levoleucovorin — drug: 200mg/ m2 given by IV every 2 weeks. · fluorouracil — drug: 400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks.
Patient visit burden: Not specified by the sponsor

In plain English

This study looks at adults with bowel cancer that has spread or cannot be removed by surgery, and whose cancer has too much of a protein called HER2. It tests whether a drug called tucatinib, given together with trastuzumab and a chemotherapy combination known as mFOLFOX6, works better than the usual standard treatment. The study is funded by Seagen, a company owned by Pfizer.

Who can take part

Cancer confirmed by laboratory testing to be a type called 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 sample of tumour tissue (or have a new biopsy taken within 35 days before starting study treatment if no stored sample exists).
Cancer tested as HER2-positive by a central laboratory.
Cancer tested as RAS wild-type (a normal RAS gene).
At least one tumour that can be measured on a scan, which has not been treated with radiotherapy, or has clearly grown since radiotherapy.
Fairly fit and active, scoring 0 or 1 on a scale used by doctors (the Eastern Cooperative Oncology Group, or ECOG, performance status).
Based on a brain scan: either no cancer spread to the brain, or previously treated brain spread that is not causing symptoms.

Who may not be able to

Previous whole-body drug treatment (systemic therapy) for bowel cancer that has spread or cannot be removed, although up to 2 doses of mFOLFOX6 are allowed. Chemotherapy given after surgery to prevent cancer returning is allowed if it finished more than 6 months before joining.
Radiotherapy within 14 days before joining (or within 7 days for a precise type called stereotactic radiosurgery).
Any previous treatment targeting HER2.
Ongoing numbness, tingling or nerve damage (neuropathy) that is Grade 3 or worse.
A hole (perforation) in the stomach or gut that is active or untreated at the time of screening.

What taking part involves

• Taking tucatinib together with trastuzumab and the chemotherapy combination mFOLFOX6, or receiving the standard treatment doctors would normally give (how the standard treatment is given is not stated — ask the trial team).
• Providing tumour tissue samples for laboratory testing.
• Having scans to measure the cancer and a brain scan (magnetic resonance imaging, or MRI) to check for spread to the brain.

Time commitment: How long the study lasts and how often visits are needed is not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 400
Started: 2022-10-24
Last checked: 2026-07

Plain English Summary

What is this study?

• Testing a new treatment for colorectal neoplasms
• Phase3 - 400 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with colorectal neoplasms

Where?

• Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust
• Glasgow - NHS Greater Glasgow & Clyde - Beatson West of Scotland Cancer Care
• Sutton - The Royal Marsden Hospital
• Bristol - University Hospitals Bristol and Weston NHS Foundation Trust
• +8 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Colorectal Neoplasms

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

HER2homolog wild-type

Treatment history

Treatments you must have had:

✓ within 35 days

What the study is looking for

✓Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is that has grown locally...
✓Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly...
✓If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required...
✓HER2+ disease as determined by a tissue based assay performed at a central laboratory.
✓Radiographically cancer that can be measured on scans v1.1 with:

Who cannot take part

✗Note: May have received drug treatment for CRC in the after surgery setting if it was completed \>6 months prior to enrollment
✗radiotherapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
✗Previous treatment with anti-HER2 therapy
✗Ongoing Grade 3 or higher neuropathy
✗Active or untreated gastrointestinal (GI) perforation at the time of screening.

See the full criteria

Inclusion Criteria: * Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic * Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment * HER2+ disease as determined by a tissue based assay performed at a central laboratory. * Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date. * Radiographically measurable disease per RECIST v1.1 with: * At least one site of disease that is measurable and that has not been previously irradiated, or * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following: * No evidence of brain metastases * Previously treated brain metastases which are asymptomatic Exclusion Criteria: * Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization. * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollment * Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery) * Previous treatment with anti-HER2 therapy * Ongoing Grade 3 or higher neuropathy * Active or untreated gastrointestinal (GI) perforation at the time of screening.