OncoMatch/Clinical Trials/NCT05253651
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
Is NCT05253651 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for colorectal neoplasms.
Treatment: tucatinib · trastuzumab · bevacizumab · cetuximab · oxaliplatin · leucovorin · levoleucovorin · fluorouracil — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2+)
HER2+ disease as determined by a tissue based assay performed at a central laboratory.
Required: KRAS wild-type
Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing.
Required: NRAS wild-type
Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing.
Required: HRAS wild-type
Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization; adjuvant chemotherapy allowed if completed >6 months prior to enrollment
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. May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
Cannot have received: HER2-targeted therapy
Previous treatment with anti-HER2 therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Palo Verde Hematology Oncology · Glendale, Arizona
- Mayo Clinic Building - Phoenix · Phoenix, Arizona
- Mayo Clinic Hospital · Phoenix, Arizona
- Mayo Clinic · Scottsdale, Arizona
- Los Angeles Cancer Network - Anaheim · Anaheim, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05253651 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS wild-type is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages