A Phase I/II Study to Evaluate Safety and Pharmacokinetics and Initial Efficacy of ZG005 in Combination With Paclitaxel Plus Cisplatin/Carboplatin ± Bevacizumab in Patients With Advanced Cervical Carcinoma

Suzhou Zelgen Biopharmaceuticals Co.,Ltd1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年3月27日最近更新: 2024年4月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
入组人数: 48
试验地点: 1
主要终点: Dose Limiting Toxicity (DLT)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multicenter, open-label phase I/II study for the first-line treatment of advanced cervical cancer.

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 70 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 18-70 years of age;
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
•Life expectancy ≥ 3 months.

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: Dose Escalation

Experimental

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

干预措施: ZG005 Powder for Injection (Drug)

Part 1: Dose Escalation

Experimental

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

干预措施: Paclitaxel (Drug)

Part 1: Dose Escalation

Experimental

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

干预措施: Bevacizumab (Biological)

Part 1: Dose Escalation

Experimental

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

干预措施: Cisplatin (Drug)

Part 1: Dose Escalation

Experimental

Part 1 is a dose escalation study of ZG005 combined with paclitaxel and platinum-based ± bevacizumab to evaluate the tolerability and safety of the combination regimen

干预措施: Carboplatin (Drug)