Product Description
Tucatinib is an investigational, oral, highly selective inhibitor of the HER2 tyrosine kinase. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/31825569/)
Mechanisms of Action: ERBB2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Accelerated Approval - Colorectal Cancer|Oncology Solid Tumor Unspecified *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Canada | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Mexico | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 48
Highest Development Phases
Phase 3: Adenocarcinoma|Breast Cancer|Colorectal Cancer|Esophageal Cancer|Gastrointestinal Cancer
Phase 2: Biliary Tract Cancer|Bladder Cancer|Brain Cancer|Brain Stem Cancer|Cervical Cancer|Cholangiocarcinoma|Lymphoma, Non-Hodgkin|Meningeal Cancer|Meningeal Carcinomatosis|Multiple Myeloma|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Small Cell Lung Cancer|Spinal Cord Cancer|Transitional Cell Carcinoma|Uterine Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2051200152 | P2 |
Active, not recruiting |
Breast Cancer |
2028-12-06 |
|
| SGNTUC-029 | P3 |
Unknown Status |
Colorectal Cancer |
2028-10-31 |
|
| Tucatinib + trastuzumab + mFOLFOX6 vs standard of care in 1L HER2+ metastatic colorectal cancer | P3 |
Active, not recruiting |
Colorectal Cancer |
2028-09-20 |
|
| NCT05892068 | P2 |
Recruiting |
Breast Cancer |
2028-05-09 |