An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Progression-free survival rate (PFSR)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:
- PFS, OS, DoR at week 48;
- antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.
详细描述
This study will be an open-label, multicenter phase II 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 12 cycles treatment and 30 days 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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
- •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
- •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
- •Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
- •Active hepatitis B or C infection
- •Inability to take medication orally
- •Abuse of alcohol or drugs
- •Pregnant or lactating women
- •People with cognitive and psychological abnormality or with low compliance
研究组 & 干预措施
WX390
Participants will receive WX390 continuous oral dosing (1.1 mg once a day).
干预措施: WX390 (Drug)
结局指标
主要结局
Progression-free survival rate (PFSR)
时间窗: Week 24 and Week 48
PFSR, Percentage of patients alive without progression from baseline.
Progression-Free Survival (PFS)
时间窗: Week 48
PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first.
Overall Survival (OS)
时间窗: Week 48
OS, time from first dose of trial medication to death due to any cause.
Objective Response Rate (ORR)
时间窗: Week 24 and Week 48
ORR, proportion of patients with complete response (CR) or partial response (PR).
Disease control rate (DCR)
时间窗: Week 24 and Week 48
DCR, proportion of patients with CR or PR or SD.
Duration of Response (DOR)
时间窗: Week 48
DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first.
次要结局
- Incidence, nature, and severity of adverse events (AEs)(Week 24 and Week 48)