Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Phase I/II Study of the PI3K Inhibitor TL117 Alone and in Combination With Paclitaxel in Patients With Relapsed/Metastatic Squamous Cell Carcinoma of the Head and Neck
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.
Status | Not yet recruiting |
Enrollment | 108 |
Est. completion date | January 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Suzhou Junde Biotechnology Co., Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment | Per DLT criteria as defined in protocol | From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days) | |
Primary | Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment | Per DLT criteria as defined in protocol | From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days) | |
Primary | Phase II - Objective response rate (ORR) | Objective response rate (ORR): percentage of patients with best overall response of complete response (CR) and partial response (PR) according to RECIST v1.1. | Every 8 weeks from date of first treatment until date of last treatment up to 12 months |
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