A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This is a multicenter, open-label phase I/II study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.
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 75 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 18-75 years of age.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic solid tumors.PART 2 Cohort A: Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Cohort B: Histologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Cohort C: Histologically confirmed unresectable locally advanced, recurrent, or metastatic other solid tumors.
- •Life expectancy ≥ 3 months.
排除标准
- •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 Gecacitinib and Chemotherapy.
干预措施: ZG005 (Drug)
Part 1: Dose Escalation
Dose-escalation study of ZG005 in combination with Gecacitinib and Chemotherapy.
干预措施: Gecacitinib (Drug)
Part 2: Dose Expansion
Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.
干预措施: ZG005 (Drug)
Part 2: Dose Expansion
Cohort A: HER2-negative gastric or gastroesophageal junction adenocarcinoma; Cohort B: Esophageal squamous cell carcinoma; Cohort C: other Solid Tumors.
干预措施: Gecacitinib (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to 2 years
Dose Limiting Toxicity (DLT)
时间窗: During the first 28 days
Objective Response Rate (ORR)
时间窗: Up to 2 years
次要结局
未报告次要终点