A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 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
Dose Exploration
The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.
干预措施: ZG005 Powder for Injection (Drug)
Dose Exploration
The first stage is a dose-exploration study of ZG005 combined with Donafenib to evaluate the safety and tolerability of different dose combinations in patients with advanced solid tumors who have failed standard therapy.
干预措施: Donafenib Tosilate Tablets (Drug)
Dose Expansion
The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.
干预措施: ZG005 Powder for Injection (Drug)
Dose Expansion
The second stage is a dose-expansion study to further evaluate the safety and initial efficacy of the combination regimen in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and other potentially beneficial solid tumors.
干预措施: Donafenib Tosilate Tablets (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 2 years
The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.
Dose Limiting Toxicity (DLT)
时间窗: Up to 2 years
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
次要结局
- Duration of response (DOR)(Up to 2 years)