A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

Exclusion Criteria

• •1. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.
• •2. Received chemotherapy, radiotherapy, biologicals, immunotherapy, or other anti-tumor drugs within 4 weeks prior to the first MRG002 treatment.
• •3. Presence of clinical manifestation of biliary obstruction.
• •4. Patients with clinical symptoms such as pleural, abdominal or pericardial effusion requiring puncture drainage.
• •5. Presence of central nervous system (CNS) metastasis and/or neoplastic meningitis.
• •6. Any severe or uncontrolled systemic diseases.
• •7. Patients with poorly controlled heart diseases.
• •8. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.
• •9. History of other primary malignancies.
• •10. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• •11. Peripheral neuropathy greater than Grade 1.
• •12. History of cirrhosis (decompensated cirrhosis Child-Pugh class B and C).
• •13. Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving within 2 weeks prior to enrollment.
• •14. Received anti-tumor vaccine treatment 4 weeks prior to the first dose or planning to participate in anti-tumor vaccine trials.
• •15. Female patents with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 6 months after the last dose of study treatment.
• •16. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.