Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Prior treatment

• 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)
• Prior or current PI3K inhibitor therapy;
• 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;
• Any unresolved toxicities from prior therapy greater than Grade 1;
• Known alcohol or drug dependence;

Other illness

• Type 1 or type 2 diabetes requiring antihyperglycemic medication;
• Inability to swallow, or serious gastrointestinal absorption conditions;
• History of immunodeficiency;
• Active hepatitis B or C virus infection;
• Uncontrolled active infection;
• Serious cardiovascular disease；
• Known allergy and/or contraindications to paclitaxel;
• Mental disorders or poor compliance;

Other

• Active central nervous system metastases;
• Clinically uncontrollable effusion in the third space;
• Pregnant or lactating women;

• 18-70 years old for Phase 1a, 18-75 years old for Phase 1b and 2;
• Histologically and/or cytologically confirmation of recurrent/metastatic squamous cell carcinoma of the head and neck;
• At least one evaluable or measurable tumor lesion;
• Adequate performance status;
• A minimum life expectancy of \> 3 months;
• Adequate cardiac, kidney, and liver function;
• Willingness of all subjects of childbearing potential to use acceptable methods of birth control;