A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody，in Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment

Sinocelltech Ltd.0 sites21 target enrollmentJanuary 2015

Overview

The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

December 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Responsible Party

Sponsor

•aged from 18 to 70 years;
•having histologically confirmed metastatic colorectal cancer;
•having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;
•having determined wild-type KRAS tumor;
•having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least ≥3 months;
•adequate hematological, renal and liver functions:
•Hematological function: white blood cell count of \>4.0×109/L; absolute neutrophil count of \>1.5×109/ L; platelet count of \>100×109/L; hemoglobin level of \>90.0 g/L;
•Renal function: serum creatinine level of\<1.5×upper limit of normal (ULN);
•Liver function: total bilirubin level of\<1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \<1.5×ULN; or \<5 × ULN for patients with liver metastases;

•had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or anti- EGFR monoclonal antibody;
•having to be at least 4 weeks beyond prior anticancer therapy (including corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or participating in other clinical trial, or have not recovered from significant toxicities of prior therapy;
•chronic use of medication that could interfere with the assessment of drug-related toxicities or immunologic activity (high dose prednisone or high dose non-steroid anti-inflammatory medication);
•had recent major surgery (within 28 days);
•with symptomatically brain metastases (with the exception of clinically brain metastases stable and of no requirement further treatment);
•with active infection requirement systemic antibiotics treatment; or serious cardiovascular disease;or with evidence of active hepatitis B or C infection; or with human immunodeficiency virus infection;
•had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic obstructive pulmonary disease (COPD) or with risk factors to COPD;
•with eye inflammation or infection, or any risk factors who could lead to eye disease;
•with a history of allergic reaction or protein product allergy including antibodies product;
•pregnant, or lactating, or not accepted birth control methods including male patients.

Number of participants with SCT200-related adverse events

Time Frame: up to 105 days

Area Under the plasma concentration versus time curve (AUC) of SCT200(prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose)