A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced solid tumors. The main questions it aims to answer are:
- the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390;
- safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.
详细描述
This study will be an open-label, multicenter phase Ib/IIa clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Life expectancy of more than 3 months
- •At least one measurable lesion according to RECIST 1.1
- •Adequate organ function，
- •Signed and dated informed consent
排除标准
- •Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
- •Major surgery within 30 days prior to the initiation of study treatment
- •Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
- •Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
- •Patients who are suffering active interstitial lung disease
- •Evidence of ongoing or active serious infection
- •History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection
- •Inability to take medication orally
- •Abuse of alcohol or drugs
- •People with cognitive and psychological abnormality or with low compliance
- •Pregnant or lactating women
研究组 & 干预措施
WX390 0.5 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
干预措施: WX390 (Drug)
WX390 0.5 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
干预措施: Toripalimab (Drug)
WX390 0.7 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.7 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
干预措施: WX390 (Drug)
WX390 0.7 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.7 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
干预措施: Toripalimab (Drug)
WX390 0.9 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
干预措施: WX390 (Drug)
WX390 0.9 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
干预措施: Toripalimab (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period
时间窗: up to 24 weeks
The safety and tolerability of WX390 will be evaluated based on adverse events data. Other safety parameters include physical examination, clinical laboratory tests including coagulation function, renal function, hepatic function, blood glucose and blood lipid, etc.
Progression-free survival rate (PFS rate)
时间窗: up to 24 weeks
PFS rate: is defined as the proportion of patients without objective tumor progression or death.
Objective response rate (ORR)
时间窗: up to 24 weeks
ORR: is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1.
次要结局
- Overall survival (OS)(up to 48 weeks)
- Disease-control rate (DCR)(up to 24 weeks)
- Progression-free survival (PFS)(up to 48 weeks)