A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

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).

本研究为一项多中心、全球性II期开放标签两部分设计的一线治疗研究，旨在探索ZW25（zanidatamab）联合标准一线联合化疗方案，针对入选的胃肠道（GI）恶性肿瘤的安全性、耐受性及抗肿瘤活性。符合入组标准的患者包括不可切除、局部进展、复发或转移性HER2阳性胃食管腺癌（GEA）、胆道癌（BTC）或结直肠癌（CRC）患者。