SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors

Exclusion criteria

• . Active brain metastases, carcinomatous meningitis, or primary central nervous system (CNS) tumors that have not been treated with surgery or radiotherapy; s
• . subjects with peripheral neuropathy (those with mild symptoms that do not require treatment and not affect the study results or increase the risk may be included as judged by the investigator);
• . Have received surgery (major surgery for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose (palliative radiotherapy within 2 weeks prior to the first dose);
• . Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
• . Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;
• . Subjects with toxicities and/or complications from prior treatment that have not recovered to NCI-CTCAE Grade ≤ 1 may be enrolled if the investigator judges that these conditions are of NCI-CTCAE Grade ≤ 2 and no safety risk to the subjects;
• . Have the following lung diseases or medical history: (1) known or suspected interstitial lung disease; (2) moderate to severe lung diseases that seriously affect lung function within the past 3 months, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), and obstructive/restrictive lung disease, which may interfere with the testing or management of treatment-related pulmonary toxicities; (3) any autoimmune, connective tissue, or inflammatory disease involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, and sarcoidosis; (4) prior pneumonectomy; (5) Grade ≥ 3 interstitial lung disease during prior treatment with immune checkpoint inhibitors. Subjects with interstitial lung changes may be enrolled if there is no safety risk as judged by the investigator;
• . Have had pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose;