Safety and Efficacy of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Wild-type RAS and BRAF mCRC

NCT ID: NCT03405272

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2019-12-01

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR Monoclonal antibody（SCT200）in patients with wild-type RAS and BRAF mCRC treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

recombinant anti-EGFR monoclonal antibody（SCT200）

Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.

Group Type: EXPERIMENTAL

Recombinant Anti-EGFR Monoclonal Antibody（SCT200）

Intervention Type: BIOLOGICAL

Experimental: recombinant anti-EGFR monoclonal antibody（SCT200） Recombinant Anti-EGFR Monoclonal Antibody（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.

Interventions

Recombinant Anti-EGFR Monoclonal Antibody（SCT200）

Experimental: recombinant anti-EGFR monoclonal antibody（SCT200） Recombinant Anti-EGFR Monoclonal Antibody（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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Able to provide written informed consent and can understand and comply with the requirements of the study;

2. Men and women ≥ 18 years of age;

3. Life expectancy of longer than 3 months ( clinical assessment);

4. With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;

5. Have been diagnosed as mCRC verified histologically;

6. Patients treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy. Disease progressed or developed non-tolerable toxicity after systemic chemotherapy：a. at least one treatment cycle should be completed, and maintenance therapy using one of the doublets is considered as the same line of therapy ; b. May have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented;

7. RAS and BRAF wildtype status of primary colorectal cancer or related metastasis;

8. 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 2.5 times IULN, or less than/equal to 5 times IULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN); Serum creatinine less than/equal to 1.5 times IULN; Electrolyte: magnesium greater than/equal to normal.

9. According to RECIST 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI. Longest diameter greater than/equal to10mm（CT scan slice thickness no greater than 5 mm）, a lymph node must be ≥15mm in short axis when assessed by CT scan.

Exclusion Criteria

1. Patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis, untreated with proper radiation therapy, showing clinical symptoms or symptom stable time less than 28 days;

2. Patients with other primary malignancies within the past 5 years except non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia;

3. Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;

4. Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;

5. 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);

6. Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices.

7. Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery.

8. Patients treated with EPO, G-CSF or GM-CSF.

9. Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia);

10. Patients occurred myocardial infarction within 6 months.

11. Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD .

12. Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);

13. Patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;

14. Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;

15. Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;

16. 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 that there may be HIV infection, there is no need to detect);

17. Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);

18. Patients have alcohol or drug addiction;

19. Inability to comply with study and/or follow-up procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yuankai shi, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Sixth Affiliated Hospital Of Sun Yat-sen University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital.

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Xiking Hospital

Xi'an, Shaanxi, China

Lin Yi Cancer Hospital

Linyi, Shandong, China

Zhongshan hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital Of Xinjiang Medical University

Ürümqi, Xinjiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

xiaoling yang

Role: CONTACT

xiaoling_yang@sinocelltech.com

0086-10-58628288 ext. 9492

Other Identifiers

SCT200mCRCⅡ

Identifier Type: -

Identifier Source: org_study_id