Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer

Exclusion Criteria

• •1. Treatment with any of the following:
• •* Previous or current treatment with EGFR Exon 20 insertion inhibitors, HER2 Exon 20 insertion inhibitors or EGFR/HER2 Exon 20 insertion inhibitors
• •* Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10376
• •* Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10376
• •* Local radiotherapy for palliation within 2 weeks of the first dose of HS-10376, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10376
• •* Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10376
• •2. Inadequate bone marrow reserve or serious organ dysfunction
• •3. Uncontrolled pleural, ascites or pericardial effusion
• •4. Untreated, symptomatic or active central nervous system metastases
• •5. Severe or poorly controlled hypertension
• •6. Immunodeficiency disease and active infectious disease
• •7. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
• •8. History of hypersensitivity to any active or inactive ingredient of HS-10376 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10376
• •9. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator
• •10. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator
• •11. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study
• •12. History of neuropathy or mental disorders, including epilepsy and dementia