Ainci (Beijing) Medical Technology Co., Ltd.

1.1 Primary Objectives To evaluate the efficacy, safety and tolerability of varlitinib combined with capecitabine. 1.2 Secondary Objectives To evaluate the pharmacokinetics of varlitinib combined with capecitabine To explore the exposure-response relationship of varlitinib To examine the effect of adding varlitinib to capecitabine on ECG parameters 1.3 Exploratory Objectives To explore the role of HER receptor family status as a predictor of varlitinib efficacy To explore the possible relationship between gene mutation status and clinical outcomes