Status:
ACTIVE_NOT_RECRUITING
Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Suzhou Junde Biotechnology Co., Ltd
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
This is a Phase 1/2 open label, single arm study, and is divided into three phases: the single-agent dose-escalation phase Ia trial, the TL117 plus paclitaxel dose-escalation phase Ib trial, and the o...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
- Type 1 or type 2 diabetes requiring antihyperglycemic medication;
- 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;
- Inability to swallow, or serious gastrointestinal absorption conditions;
- History of immunodeficiency;
- Active central nervous system metastases;
- Active hepatitis B or C virus infection;
- Uncontrolled active infection;
- Serious cardiovascular disease；
- Clinically uncontrollable effusion in the third space;
- Known allergy and/or contraindications to paclitaxel;
- Known alcohol or drug dependence;
- Mental disorders or poor compliance;
- Pregnant or lactating women;
Key Trial Info
Start Date :
May 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04843098
Start Date
May 26 2021
End Date
June 1 2025
Last Update
December 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120