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Clinical Trials in China / NCT04843098
Active, not recruiting Phase 1/2

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

NCT04843098 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Junde Biotechnology Co., Ltd
Phase
Phase 1/2
Started
2021-05-26
Last updated
2024-12-09

Condition(s) studied

Head and Neck Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

TL117Paclitaxel →

TL117: TL117 capsules orally once daily

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)

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital Shanghai Shanghai Municipality

Other trials for the same condition

Official registry record

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.

View NCT04843098 on ClinicalTrials.gov ↗ ← All trials in China