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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
TL117 capsules orally once daily
Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Phase Ia -Dose Limiting Toxicity (DLT) of TL117 treatment
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)
Phase Ib -Dose Limiting Toxicity (DLT) of TL117 plus paclitaxel combination treatment
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)
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.
Time frame: Every 8 weeks from date of first treatment until date of last treatment up to 12 months
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