Pucotenlimab Combined with MRG002 for HER2-positive Cancer of Unknown Primary

Exclusion Criteria

• •1. History of other primary malignancies.
• •2. Received prohibited treatments as per the protocol.
• •3. Untreated or unstable brain metastases, spinal metastases or compression, carcinomatous meningitis, or leptomeningeal metastases.
• •4. Presence of ascites, pleural effusion, pericardial effusion that cannot be controlled by drainage methods, or subjects who require drainage to control third-space effusions within 14 days before dosing.
• •5. Any severe or uncontrolled systemic disease, as judged by the investigator, including poorly controlled hypertension, uncontrolled diabetes, or signs of active bleeding.
• •6. History of uncontrolled cardiac disease, including heart failure greater than NYHA Class II, unstable angina, myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmias requiring treatment, or prolonged QT syndrome.
• •7. Evidence of active infection, including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections, unless treated and resolved before administration of the investigational drug.
• •8. History of allergy to Pucotenlimab or any component of MRG002, or history of ≥Grade 3 allergic reaction to macromolecular protein preparations/monoclonal antibodies.
• •9. History of primary immunodeficiency or active autoimmune disease, current use of immunosuppressive agents, or systemic corticosteroid therapy (≥10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
• •10. History of or concurrent interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
• •11. Positive serum pregnancy test or breastfeeding women who do not agree to adequate contraception during the study and for 6 months after receiving the investigational drug.
• •12. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.