Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors

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追踪信息

首次提交日期 ^ICMJE

September 29, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

September 30, 2018

预计主要完成日期

November 30, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Objective response rate (ORR)[ Time Frame: 1 year ]

ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Adverse events (AEs)[ Time Frame: 1 year ]
AE are assessed according to NCI CTCAE v4.03.
Progress Free Survival ( PFS)[ Time Frame: 1 year ]
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.
Disease control rate (DCR)[ Time Frame: 1 year ]
The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
Overall survival (OS)[ Time Frame: 1 year ]
OS is defined as time from first dose of SCT200 until the date of death from any cause.

描述性信息

简略标题 ^ICMJE

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors

正式标题 ^ICMJE

Recombinant Anti-EGFR Monoclonal Antibody（SCT200）in Patients With Advanced Solid Tumors or Lymphoma : A Phase Ⅰb, Open-label, Multicenter Study.

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 1

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Biological: SCT200
Recombinant Anti-EGFR Monoclonal Antibody （SCT200）

研究工具

Experimental: SCT200
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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

April 30, 2020

预计主要完成日期

November 30, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Able to provide written informed consent and can understand and comply with the requirements of the study; - Males or females. Aged 18 to 75 years old; - Life expectancy of longer than 3 months ( clinical assessment); - With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1; - Histological or cytological diagnosis of advanced solid tumors(gastric/gastroesophageal junction cancer, hepatocellular carcinoma,pancreatic cancer,gallbladder cancer/bile duct cancer，renal cell carcinoma，ovarian cancer，other advanced solid tumor) - Advanced solid tumor or lymphoma wuth failure of standard treatment; - According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed; - Adequate organ and marrow function as defined below: 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: - Patients who are allergic to analogue of SCT200 and/or its inactive ingredients; - Patients with active central nervous system metastasis or a history of central nervous system metastasis;(If the subject has been suspected with central nervous system metastasis,imaging examination confirmation must be performed within 28 days to exclude central nervous system metastasis; - Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated within 28 days prior to study. (If the subject has received bisphosphonate or denosumab treatment prior to study and showing stable time at least 28 days,the subject will be allowed to use it.) Subjects who were enrolled in this study may start taking bisphosphonate or denosumab for bone metastases after the first assessment of the efficacy. - Patients with other primary malignancies, except cured of basal cell carcinoma skin cancer, carcinoma in situ of cervix, or prostatic intraepithelial neoplasia; - Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody; - Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less); - Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices. - Prior to the first dose of study drug, patients received major surgery requiring general anesthesia has been completed less than 4 weeks; surgery requiring local anesthesia/epidural anesthesia has been completed less than 72 hours; skin biopsy requiring local anesthesia has been completed less than 1 hour. - Patients treated with EPO, G-CSF or GM-CSF. - Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia); - Patients occurred myocardial infarction within 6 months. - Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD . - Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites); - Patients with medical or psychiatric condition or laboratory abnormality may interfere with the interpretation of study results; - Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment; - Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and for at least 6 months after your last dose of SCT200; - Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting HIV infection, there is no need to detect); - Patients with uncontrolled active infections within 2 weeks before enrollment (except urinary tract infection or upper respiratory tract infection); - Patients have alcohol or drug addiction; - Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator，such as inability to comply with study and/or follow-up procedures.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：75 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Sinocelltech Ltd.

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: jianming xu, MD 307 Hospital of PLA

PRS 账户

验证日期

June 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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