A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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-
- •Histologically confirmed recurrent or metastatic neuroendocrine carcinoma
- •Life expectancy ≥ 3 months.
排除标准
- •Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;
- •Any other malignancy within 5 years.
- •participants 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
Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.
干预措施: ZG005 (Biological)
Part 1: Dose Escalation
Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.
干预措施: Etoposide (Drug)
Part 1: Dose Escalation
Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.
干预措施: Cisplatin (Drug)
Part 2: Dose Expansion
Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
干预措施: ZG005 (Biological)
Part 2: Dose Expansion
Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
干预措施: Etoposide (Drug)
Part 2: Dose Expansion
Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
干预措施: Cisplatin (Drug)
Part 2: Dose Expansion
Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Event (AE)
时间窗: Up to 2 years
Number of participants with adverse events that are related to treatment
Dose Limiting Toxicity (DLT)
时间窗: Up to 2 years
Objective Response Rate (ORR)
时间窗: Up to 2 years
ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented
次要结局
未报告次要终点