A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
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 Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:
- Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.
- 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 II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 28-days 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
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Histological or cytological confirmed advanced Gastric-type Endocervical Adenocarcinoma.
- •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 organic 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 + Toripalimab
Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks).
干预措施: WX390 (Drug)
WX390 + Toripalimab
Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks).
干预措施: Toripalimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 24 weeks
ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) confirmed by RECIST v1.1 assessment.
Progression-free survival rate (PFS rate)
时间窗: up to 24 weeks
PFS rate, defined as the proportion of patients who have not experienced disease progression (PD) or death due to any cause during the study period.
次要结局
- Overall survival (OS)(up to 48 weeks)
- Progression-free survival (PFS)(up to 24 weeks)
- Time to reach plasma Cmax (Tmax) of WX390(up to 24 weeks)