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The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody(SCT200)in patients with advanced solid tumors treated after failure of standard therapy.
This open label, multicenter phase Ib study is designed to evaluate Objective Response Rate (ORR) in advanced solid tumors (gastric/gastroesophageal junction cancer, hepatocellular carcinoma,pancreatic cancer,gallbladder cancer/bile duct cancer,renal cell carcinoma,ovarian cancer,or other advanced solid tumor) treated with anti-EGFR monoclonal antibody SCT200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT200 | Experimental | Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT200 | Biological | Recombinant Anti-EGFR Monoclonal Antibody (SCT200) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | AE are assessed according to NCI CTCAE v4.03. | 1 year |
| Progress Free Survival ( PFS) | PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria. |
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Inclusion Criteria:
Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianming xu, MD | 307 Hospital of PLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital of PLA | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 1 year |
| Disease control rate (DCR) | The achievement of any a stable response(SD), partial response (PR) or complete response (CR), according to RECIST v1.1 criteria. | 1 year |
| Overall survival (OS) | OS is defined as time from first dose of SCT200 until the date of death from any cause. | 1 year |