Eligibility criteria+1,963 characters
Inclusion Criteria:
Age ≥18 years,;
Histologically regardlessor ofcytology-confirmed gender.
UnresectableHER2-positive locally advanced, recurrent, or metastatic gastric cancer (including gastricadenocarcinoma of the gastro-esophageal junction adenocarcinoma) confirmed by histopathology and/or cytology; HER2 positive expression is defined as IHC 3+, or IHC 2+ with ISH test positive (HER2/CEP17 ratio ≥ 2.
Stage 1: Progression on0, or aftermean HER2 copy number ≥1st 6.0 signals/cell);
Failure of at least first-line treatmentstandard fortherapy gastric(trastuzumab carcinoma.
Stageplus 2chemothera [...] [...]
Secondary endpoints4 to 8 entries
Progression Free Survival (PFS) according to RECIST 1.1 by Investigator's Assessment
The concentration of KN026 drug in serum
Incidence and titer of anti-drug antibody (ADA)
Incidence of neutralizing Antibody，Nab
Study description+63 characters
ThisKN026-001 is a two-stage randomized, multicenter, phase Ⅱ/Ⅲ clinical study to evaluate the efficacy of KN026 in patientscombination with chemotherapy in subjects with HER2-positive, advanced unresectable or metastatic gastric orcancer, including adenocarcinoma of the gastro-esophageal junction (GEJ) adenocarcinoma, who have progressedfailed onfirst-line or after a trastuzumab-containing regimentherapy.
Stage 1 is an open-label, multicenter, phase IIⅡ study ofto KN026 and paclitaxel or irinotecan when given together.
Onceevaluate the safety and efficacy have been establishedORR in Stagesubj [...] [...]
Study title-9 characters
KN026 in Combination With Chemotherapy in the Second Line Treatment of HER-2HER2 Positive Advanced or Metastatic Gastric Cancer Subjects Who Have Failed First-line Therapy