A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dose limited toxicity(DLT)
研究概览
简要总结
This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand this study and voluntarily sign the ICF.
- •Age 18-75 years, no gender restriction.
- •Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.
排除标准
- •Medical history, CT scan, or MRI indicates the presence of CNS metastases.
- •Other malignancies within 5 years.
- •Any other reason deeming the participant unsuitable for the study, as judged by the investigator.
研究组 & 干预措施
Phase 1 Dose Escalation
ZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
干预措施: ZGGS18 for Injection (Biological)
Phase 1 Dose Escalation
ZG005 will be given 10mg/kg or 20mg/kg or other dose every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
干预措施: ZG005 for Injection (Biological)
Phase 2 Dose Expansion
ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
干预措施: ZGGS18 for Injection (Biological)
Phase 2 Dose Expansion
ZG005 will be given RP2D every three weeks and ZGGS18 will be given 10 mg/kg every three weeks
干预措施: ZG005 for Injection (Biological)
结局指标
主要结局
Dose limited toxicity(DLT)
时间窗: up to 21 days
Incidence and severity of DLT events
Adverse Event (AE)
时间窗: Up to 2 years
Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.
Maximum tolerated dose(MTD)
时间窗: Up to 1 years
Recommended phase II dose(RP2D)
时间窗: Up to 1 years
次要结局
- Immunogenicity(Up to 2 years)
- Objective response rate (ORR)(Up to 2 years)