Also known as: Tukysa
Tucatinib is marketed as TUKYSA, an oral kinase inhibitor used in HER2-positive advanced or metastatic breast cancer (with trastuzumab and capecitabine) and in RAS wild-type HER2-positive unresectable or metastatic colorectal cancer (with trastuzumab). The colorectal indication is under accelerated approval. U.S. initial approval was in 2020.
Over 20 pharmaceutical companies are developing therapies for HER2-positive gastric cancer, with multiple Phase III trials launched in March 2026 testing novel combination treatments for advanced disease.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07494448 |
Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07413939 |
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive |
RECRUITING | PHASE2/PHASE3 |
| NCT07318389 |
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer |
NOT_YET_RECRUITING | EARLY_PHASE1 |
| NCT06961331 |
Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer. |
COMPLETED | |
| NCT06686394 |
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) |
RECRUITING | PHASE1/PHASE2 |
| NCT06439693 |
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer |
RECRUITING | PHASE2 |
| NCT06239467 |
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer |
RECRUITING | PHASE1 |
| NCT06162559 |
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study |
RECRUITING | PHASE1 |
| NCT06157892 |
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors |
RECRUITING | PHASE2 |
| NCT06067776 |
Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer |
NOT_YET_RECRUITING | PHASE1 |
