Tests tucatinib with other drugs in HER2-positive colorectal cancer
Tests tucatinib with trastuzumab and chemotherapy against standard treatment in adults with HER2-positive colorectal cancer.
Key facts
- Who runs it
- Seagen, a wholly owned subsidiary of Pfizer
- Where
- Cork, Dublin 4, Dublin 7, Dublin 9, and Waterford, IrelandSee the 7 sitesAlso in 25 other countries, 335 sites
- Registry title
- A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 400 people, planned
- Started
- 24 Oct 2022
- Expected to end
- 3 Jul 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- tucatinib
- trastuzumab
- bevacizumab
- cetuximab
- oxaliplatin
- leucovorin
- levoleucovorin
- fluorouracil
- Record updated
- 22 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HER2-positive, RAS wild-type colon or rectal cancer that has spread or cannot be removed by surgery, and who have not yet had treatment for it in this stage.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Adenocarcinoma of the colon or rectum that is locally advanced and cannot be removed by surgery, or has spread (metastatic). The cancer must be measurable on scans. ECOG performance status of 0 or 1.
- Earlier treatment
- No earlier drug treatment for this stage of colorectal cancer, except at most 2 doses of mFOLFOX6 before randomization. Chemotherapy after surgery is allowed if it ended more than 6 months before joining. No earlier anti-HER2 treatment.
- Biomarker or test result
- HER2-positive disease, shown by a tissue test at a central laboratory. RAS wild-type disease, shown by local or central testing. A tumor tissue sample must be provided.
Main reasons for not taking part
- Earlier systemic cancer treatment for this stage of colorectal cancer (beyond 2 doses of mFOLFOX6)
- Earlier treatment with anti-HER2 therapy
- Radiation therapy within 14 days before joining (7 days for stereotactic radiosurgery)
- Ongoing neuropathy of Grade 3 or higher
- Active or untreated gastrointestinal perforation
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Active or untreated gastrointestinal (GI) perforation at the time of screening
- Ongoing Grade 3 or higher neuropathy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
- Which best describes how well you can look after yourself and be active?
Where in Ireland
Also in 25 other countries, 335 sites
- Bon Secours Hospital CorkCork, IrelandTaking people
- Cork University HospitalCork, IrelandTaking people
- St Vincent's University HospitalDublin 4, IrelandTaking people
- Mater Misericordiae University HospitalDublin 7, IrelandTaking people
- Mater Private HospitalDublin 7, IrelandTaking people
- Beaumont HospitalDublin 9, IrelandTaking people
- University Hospital WaterfordWaterford, IrelandTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Tucatinib ArmTreatment being tested
Tucatinib + trastuzumab + mFOLFOX6
Treatment: tucatinib, trastuzumab, oxaliplatin, leucovorin, levoleucovorin, and fluorouracil
- Standard of Care ArmExisting treatment, for comparison
Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab
Treatment: bevacizumab, cetuximab, oxaliplatin, leucovorin, levoleucovorin, and fluorouracil
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
- Plain-language title
- Tests tucatinib with other drugs in HER2-positive colorectal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05253651, who can take part
- Record updated
- 22 July 2026