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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, pharmacokinetic and efficacy of TL117 plus paclitaxel in patients with recurrent or metastatic head and neck cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Junde Biotechnology Co., Ltd
• Treatments: Paclitaxel

Criteria

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;