Clinical Research Directory

Inclusion Criteria: 1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma 2. HER2 positive or HER2 gene mutation; 3. Meet the requirements of previous treatment; 4. ECOG performance status of 0 or 1； 5. Expected survival ≥ 3 months; 6. No serious abnormalities in hematopoietic function, liver or kidney function; 7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.; 8. Fully informed subjects who voluntarily sign the ICF. Exclusion Criteria: 1. Subjects who have previously received anti-HER2 molecular targeted therapy; 2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose; 3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator; 5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.