A Phase 1/2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
This is a multi-center, open-label, Phase 1/2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD/recommended dose.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the study and voluntarily sign the informed consent form.
- •Male or female 18-70 years of age;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
- •Life expectancy ≥ 3 months;
- •Histologically or cytologically confirmed diagnosis of advanced solid tumors.
排除标准
- •Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;
- •Any other malignancy within 5 years.
研究组 & 干预措施
Part 1: Dose Escalation
The study will begin with open-label dose escalation in ZG005 monotherapy treatment to determine the Maximum tolerated dose (MTD).
干预措施: ZG005 Powder for Injection (Biological)
Part 2: Dose Expansion: Recommended Phase 2 Dose (RP2D) of ZG005 monotherapy
The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.Single drug dose expansion was performed in different tumors, such as :Non-small cell lung cancer, small cell lung cancer, Esophageal squamous cell carcinoma, Alveolar soft part sarcoma
干预措施: ZG005 Powder for Injection (Biological)
结局指标
主要结局
Adverse Event (AE)
时间窗: Up to 24 Months
Number of participants with adverse events that are related to treatment
Dose Limiting Toxicities (DLT)
时间窗: Up to 21Days
A DLT is defined as any of the following ≥ Grade 3 adverse events occurring from the first dose to the end of first Cycle (21 days), unless the investigator deems that the AE is clearly related to the disease progress or definitely due to an external cause.
Objective Response Rate
时间窗: Up to 24 Months
Objective response rate was based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Maximum tolerated dose (MTD)
时间窗: Up to 24 Months
During the dose escalation stage, if 2 of up to 6 subjects in the first dose groups experienced DLT, then the dose level will be considered to be an intolerable dose or DLT dose level, and the previous lower dose will be considered to be the MTD.
次要结局
未报告次要终点