Clinical Research Directory

Inclusion Criteria: 1. 18-70 years old for Phase 1a, 18-75 years old for Phase 1b and 2; 2. Histologically and/or cytologically confirmation of recurrent/metastatic squamous cell carcinoma of the head and neck; 3. At least one evaluable or measurable tumor lesion; 4. Adequate performance status; 5. A minimum life expectancy of \> 3 months; 6. Adequate cardiac, kidney, and liver function; 7. Willingness of all subjects of childbearing potential to use acceptable methods of birth control; Exclusion Criteria: 1. Any chemotherapy, radiotherapy, targeted therapy, immunotherapy, endocrine therapy and other systematic anti-tumor therapies within 4 weeks prior to the first dose of the study drug (some exceptions apply) 2. Prior or current PI3K inhibitor therapy; 3. Type 1 or type 2 diabetes requiring antihyperglycemic medication; 4. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or required elective surgery during the study period; 5. Any unresolved toxicities from prior therapy greater than Grade 1; 6. Inability to swallow, or serious gastrointestinal absorption conditions; 7. History of immunodeficiency; 8. Active central nervous system metastases; 9. Active hepatitis B or C virus infection; 10. Uncontrolled active infection; 11. Serious cardiovascular disease； 12. Clinically uncontrollable effusion in the third space; 13. Known allergy and/or contraindications to paclitaxel; 14. Known alcohol or drug dependence; 15. Mental disorders or poor compliance; 16. Pregnant or lactating women;