Paclitaxel: Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment — From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days) Per DLT criteria as defined in protocol
Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment — From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days) Per DLT criteria as defined in protocol
Phase II - Objective response rate (ORR) — Every 8 weeks from date of first treatment until date of last treatment up to 12 months Objective response rate (ORR): percentage of patients with best overall response of complete response (CR) and partial response (PR) according to RECIST v1.1.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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