Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 23
- 主要终点
- Incidence of adverse events (Part 1)
研究概览
简要总结
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).
详细描述
Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy (XELOX, FP, or mFOLFOX6 for GEA; mFOLFOX6 with or without bevacizumab for CRC; and CisGem for BTC) and will confirm the recommended dosage (RD) of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens. Then, Part 2 of the study will evaluate the anti-tumor activity of ZW25 plus combination chemotherapy in HER2-expressing GEA, BTC, and CRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ZW25 + FP
ZW25 plus fluorouracil (5-FU) and cisplatin
干预措施: ZW25 (Zanidatamab) (Drug)
ZW25 + FP
ZW25 plus fluorouracil (5-FU) and cisplatin
干预措施: Cisplatin (Drug)
ZW25 + FP
ZW25 plus fluorouracil (5-FU) and cisplatin
干预措施: Fluorouracil (Drug)
ZW25 + mFOLFOX6
ZW25 plus 5-FU, leucovorin, and oxaliplatin
干预措施: ZW25 (Zanidatamab) (Drug)
ZW25 + mFOLFOX6
ZW25 plus 5-FU, leucovorin, and oxaliplatin
干预措施: Fluorouracil (Drug)
ZW25 + mFOLFOX6
ZW25 plus 5-FU, leucovorin, and oxaliplatin
干预措施: Leucovorin (Drug)
ZW25 + mFOLFOX6
ZW25 plus 5-FU, leucovorin, and oxaliplatin
干预措施: Oxaliplatin (Drug)
ZW25 + XELOX
ZW25 plus capecitabine and oxaliplatin
干预措施: ZW25 (Zanidatamab) (Drug)
ZW25 + XELOX
ZW25 plus capecitabine and oxaliplatin
干预措施: Capecitabine (Drug)
ZW25 + XELOX
ZW25 plus capecitabine and oxaliplatin
干预措施: Oxaliplatin (Drug)
ZW25 + mFOLFOX6 with bevacizumab
ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
干预措施: ZW25 (Zanidatamab) (Drug)
ZW25 + mFOLFOX6 with bevacizumab
ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
干预措施: Fluorouracil (Drug)
ZW25 + mFOLFOX6 with bevacizumab
ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
干预措施: Leucovorin (Drug)
ZW25 + mFOLFOX6 with bevacizumab
ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
干预措施: Oxaliplatin (Drug)
ZW25 + mFOLFOX6 with bevacizumab
ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
干预措施: Bevacizumab (Drug)
ZW25 + CisGem
ZW25 plus cisplatin and gemcitabine
干预措施: Cisplatin (Drug)
ZW25 + CisGem
ZW25 plus cisplatin and gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Incidence of adverse events (Part 1)
时间窗: Up to 11 months
Number of participants who experienced an adverse event
Objective response rate (ORR) (Part 2)
时间窗: Up to 10 months
Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Incidence of dose-limiting toxicities (DLTs) (Part 1)
时间窗: Up to 6 weeks
Number of participants who experienced a DLT. DLTs include adverse events considered to be related to study treatment, including the evaluated dose level of ZW25, any component or combination of the components of a chemotherapy regimen, or the combination of ZW25 plus a chemotherapy regimen.
Incidence of lab abnormalities (Part 1)
时间窗: Up to 11 months
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology and chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
次要结局
- End of infusion concentration of ZW25 (Parts 1 and 2)(Up to 11 months)
- Overall survival (Parts 1 and 2)(Up to 2 years)
- Duration of response (Parts 1 and 2)(Up to 2 years)
- Trough concentration of ZW25 (Parts 1 and 2)(Up to 11 months)
- Incidence of adverse events (Part 2)(Up to 11 months)
- Incidence of lab abnormalities (Part 2)(Up to 11 months)
- Objective response rate (ORR) (Part 1)(Up to 10 months)
- Incidence of anti-drug antibodies (ADAs) (Parts 1 and 2)(Up to 11 months)
- Disease control rate (Parts 1 and 2)(Up to 10 months)
- Clinical benefit rate (Parts 1 and 2)(Up to 2 years)
- Progression-free survival (Parts 1 and 2)(Up to 2 years)
- Maximum serum concentration of ZW25 (Parts 1 and 2)(Up to 11 months)