1437TiP Phase Ib/II, open label, dose escalation and expansion trial of tucatinib in combination with trastuzumab and oxaliplatin-based chemotherapy in patients with unresectable or metastatic HER2+ gastrointestinal cancers (trial in Progress)

Abstract

Human epidermal growth factor receptor 2 (HER2) gene amplification or protein overexpression (HER2+) occurs in many gastrointestinal (GI) cancers, and HER2-targeting strategies are improving outcomes. Tucatinib (TUC), approved in multiple regions for HER2+ metastatic breast cancer, is a highly selective HER2-directed tyrosine kinase inhibitor with minimal EGFR inhibition. In patient (pt) derived xenograft models of HER2+ tumors, TUC + trastuzumab (T) showed superior anti-tumor activity compared with either agent alone (Kulukian 2020).