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This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The trial consists of two groups. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2 will receive KN026+KN046+XELOX.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN026 combined with KN046 | Experimental | KN026 combined with KN046 |
|
| KN026,KN046 and XELOX | Experimental | KN026,KN046 and XELOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN026 | Drug | KN026:30 mg/kg Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | Event-free survival (assessed by the investigator per RECIST v1.1 criteria) | from enrollment until firstly confirmed and recorded disease progression or death,assessed up to 3 years |
| Disease-free survival (DFS) |
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Inclusion Criteria:
Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation);
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| C519688 | XELOX |
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| KN046 |
| Drug |
KN046:5 mg/kg Q3W |
|
| XELOX | Drug | Oxaliplatin 130mg/m2 d1,Capecitabine 1000mg/m2 d1-14,Q3W |
|
Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
| from the start of surgery to disease recurrence or death (for any reason),assessed up to 3 years |
| overall survival (OS) | overall survival | From date of randomization until the date of death from any cause, assessed up to 5 years |