A Study of SHR-4602 in Subjects With Advanced Malignant Solid Tumors
Trial Parameters
Brief Summary
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Eligibility Criteria
Inclusion Criteria: 1. Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; 2. At least one measurable lesion based on RECIST v1.1 criteria; 3. ECOG PS score: 0-1 points; 4. Expected survival period ≥ 3 months; 5. Adequate organ function; 6. Must take one medically approved contraceptive measure; 7. Patients voluntarily joined the study and signed informed consent. Exclusion Criteria: 1. Patients with known CNS metastasis or hepatic encephalopathy; 2. Suffering from peripheral neuropathy; 3. History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period; 4. Patients with any active, known or suspected autoimmune disorder; 5. With known severe allergic reactions to any other monoclonal antibodies; 6. Pa