NCT05584800招募中1 期
A Phase I/II Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Tolerability of ZGGS18
研究概览
简要总结
A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors
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
- •Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Life expectancy ≥ 3 months;
- •Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.
排除标准
- •The investigator considers that any subjects are not suitable to participate in the trial.
研究组 & 干预措施
Dose Escalation
Experimental
干预措施: ZGGS18 for Injection (Biological)
Dose Expansion
Experimental
Tumor type: colorectal cancer，pancreatic cancer
干预措施: ZGGS18 for Injection (Biological)
结局指标
主要结局
Tolerability of ZGGS18
时间窗: 28 days
Dose limiting toxicity, number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Safety of ZGGS18
时间窗: Through study completion, an expected average of 3 years
Number of participants with adverse events/abnormal laboratory values that are related to treatment
次要结局
- Immunogenicity of ZGGS18(Through study completion, an expected average of 3 years)
- Pharmacokinetic characteristics of ZGGS18(Through Phase I study completion, an expected average of 1 year)
- Efficacy of ZGGS18(Through study completion, an expected average of 3 years)
研究者
研究点 (2)
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