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This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.
The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 overexpression | Experimental | HER2 IHC 3+ or IHC2+ and ISH+ |
|
| HER2 expression | Experimental | HER2 IHC 2+ISH- or IHC 1+ and ISH+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN026 10 mg/kg QW | Drug | 10 mg/kg QW as safety run-in dosage |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria | 1 years |
| DOR | clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria | 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital of PLA | Beijing | Beijing Municipality | 100071 | China |
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| KN026 20 mg/kg Q2W | Drug | 20 mg/kg Q2W as target dosage |
|
| KN026 30 mg/kg Q3W | Drug | 30 mg/kg Q3W as another target dosage |
|