This is a two-stage study in patients with HER2-positive, unresectable or metastatic gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen. Stage 1 is an open-label, multicenter, phase II study of KN026 and paclitaxel or irinotecan when given together. Once the safety and efficacy have been established in Stage 1, patients will be enrolled into Stage 2. Stage 2 is a randomized, multicenter, phase III study designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.