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).
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Incidence of dose-limiting toxicities (DLTs) (Part 1)
Timeframe: Up to 6 weeks
Incidence of adverse events (Part 1)
Timeframe: Up to 11 months
Incidence of lab abnormalities (Part 1)
Timeframe: Up to 11 months
Objective response rate (ORR) (Part 2)
Timeframe: Up to 10 months