At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically documented metastatic and/or unresectable adenocarcinoma of colon or rectum
- ✓RAS wild-type in primary or metastatic tumor tissue by expanded RAS testing
- ✓HER2-positive disease confirmed by CLIA/ISO-certified lab: either 3+ IHC, or 2+ IHC with HER2 amplification by FISH/CISH, or ERBB2 amplification by NGS
- ✓Prior treatment with fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF monoclonal antibody, and anti-PD-(L)1 therapy (if MSI-H or dMMR) unless contraindicated
- ✕Prior treatment with anti-HER2 targeting therapy
- ✕Systemic anticancer therapy, non-CNS radiation, or experimental agent within 3 weeks of first study dose
- ✕Unresolved Grade >1 toxicity from prior cancer therapies (except alopecia/neuropathy Grade ≤2, resolved Grade ≤1 CHF, resolved Grade ≤2 anemia/ANC decrease)
- ✕Clinically significant cardiopulmonary disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
MOUNTAINEER: A Phase II, Open Label Study of Tucatinib Combined With Trastuzumab in Patients With HER2+ Metastatic Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating Trastuzumab and Tucatinib for Metastatic Colorectal Adenocarcinoma. Completed, enrolled 117 participants across 56 sites in 5 countries.
Detailed Summary
This trial studies how well the drug tucatinib works when given with trastuzumab and when given by itself. The participants in this trial have HER2-positive (HER2+) metastatic colorectal cancer (mCRC). 'Metastatic' means that the cancer has spread to other parts of the body. In the first part of this study, participants enrolled into Cohort A and received both tucatinib and trastuzumab. In the second part of this study, participants are randomly assigned to either Cohort B or Cohort C. Participants in Cohort B will receive tucatinib and trastuzumab. Participants in Cohort C will receive tucatinib. Participants in Cohort C who do not respond to therapy may have an option to receive tucatinib plus trastuzumab.
Study Details
Timeline
Interventions
Given intravenously (into the vein; IV)
Given orally