A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
This is a multicenter, open-label phase I/II study in patients with advanced cervical cancer designed to evaluate the safety, tolerability, and preliminary efficacy of ZG005 in combination with Gecacitinib ± bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fully understand the study and voluntarily sign the informed consent form.
- •Female 18-75 years of age;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Histologically or cytologically confirmed advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
排除标准
- •Patients were deemed unsuitable for participating in the study by the investigator for any reasons.
研究组 & 干预措施
PART 1（phaseⅠ）
Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen
干预措施: ZG005 (Biological)
PART 1（phaseⅠ）
Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen
干预措施: Gecacitinib (Drug)
PART 1（phaseⅠ）
Part 1 is a dose exploratory study of ZG005 combined with gecaxitinib ± bevacizumab to evaluate the tolerability and safety of the combination regimen
干预措施: Bevacizumab (Biological)
PART 2（phase II）
Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1
干预措施: ZG005 (Biological)
PART 2（phase II）
Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1
干预措施: Gecacitinib (Drug)
PART 2（phase II）
Part 2 is a dose expansion study to further evaluate the safety and preliminary efficacy of the combination regimen identified in Part 1
干预措施: Bevacizumab (Biological)
结局指标
主要结局
Adverse Event (AE)
时间窗: Up to 2 years
Objective response rate (ORR)
时间窗: Up to 2 years
次要结局
未报告次要终点