Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TL117
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm, open label
Arm Description
Phase 1a: All subjects receiving TL117 alone (20-120 mg); Phase 1b: All subjects receiving TL117 (MTD-1 or MTD) plus Paclitaxel; Phase 2: All subjects receiving TL117 in combination with Paclitaxel at RP2D
Outcomes
Primary Outcome Measures
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment
Per DLT criteria as defined in protocol
Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment
Per DLT criteria as defined in protocol
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04843098
First Posted
March 19, 2021
Last Updated
April 9, 2021
Sponsor
Suzhou Junde Biotechnology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04843098
Brief Title
Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Junde Biotechnology Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 open label, multicenter phase 2 trial of TL117 plus paclitaxel.
Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 28. When the maximum tolerated dose (MTD) of TL117 plus paclitaxel is determined, additional patients will be treated at the defined RP2D dose until occurrence of unacceptable toxicity, disease progression or withdrawal of consent or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm, open label
Arm Type
Experimental
Arm Description
Phase 1a: All subjects receiving TL117 alone (20-120 mg); Phase 1b: All subjects receiving TL117 (MTD-1 or MTD) plus Paclitaxel; Phase 2: All subjects receiving TL117 in combination with Paclitaxel at RP2D
Intervention Type
Drug
Intervention Name(s)
TL117
Intervention Description
TL117 capsules orally once daily
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle.
Primary Outcome Measure Information:
Title
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment
Description
Per DLT criteria as defined in protocol
Time Frame
From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days)
Title
Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment
Description
Per DLT criteria as defined in protocol
Time Frame
From time of the first dosing to time of Cycle 1 Day 28(each cycle is 28 days)
Title
Phase II - Objective response rate (ORR)
Description
Objective response rate (ORR): percentage of patients with best overall response of complete response (CR) and partial response (PR) according to RECIST v1.1.
Time Frame
Every 8 weeks from date of first treatment until date of last treatment up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Guo, Dr
Phone
021-38804518
Email
pattrickguo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Peng, Dr
Phone
021-38804518
Email
pengwei8324@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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