Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma

NCT03817567 | Unknown Phase 1

• 1 other identifier: SCT200IbmESCC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Carcinoma; Carcinoma, Squamous Cell; Esophageal Neoplasms; Neoplasms, Squamous Cell; Esophageal Diseases; Epidermal growth factor receptor; EGFR; SCT200

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (4)

• Adverse events (AEs)

  one year

• PFS

  one year

• Duration of response (DOR)

  one year

• Overall survival (OS)

  one year

Study Arms (1)

recombinant anti-EGFR monoclonal antibody（SCT200）

EXPERIMENTAL

6.0mg/kg QW for 6 weeks, then 8.0mg/kg Q2W

Drug: recombinant anti-EGFR monoclonal antibody

Interventions

recombinant anti-EGFR monoclonal antibody DRUG

Experimental: 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.

Also known as: SCT200

recombinant anti-EGFR monoclonal antibody（SCT200）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females. Aged 18 to 75 years old;
• Histologically or cytologically proven squamous cell carcinoma of the esophagus, which is locally unresectable or distant metastatic disease;
• Disease progressed following standard therapies. Patients has treated with taxane/platinum/fluorouracil and/or radiotherapy. Failure of standard therapy ：Disease progressed or developed non-tolerable toxicity during or within 3 months after last systemic chemotherapy or radical concurrent chemoradiotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy;
• According to RECIST 1.1 , patients must have at least one measurable lesion which was not treated with local treatment such as radiotherapy. Tumour lesions situated in a previously irradiated area which have been demonstrated progression in the lesion, are considered measurable;
• With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• Life expectancy of longer than 3 months ( clinical assessment);
• 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.
• Women of childbearing potential must not be pregnant as assessed by a negative urine or serum beta HCG test upon admission to the hospital, and must agree to use adequate contraception during the study until to 6 months after the last dose of SCT200.For male,if his sexual partners is child-bearing potential, he should use effective contraception from the time of signing the informed consent form until at least 6 months after the last dose of study drug.
• Able to provide written informed consent and can understand and comply with the requirements of the study;

You may not qualify if:

• 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;
• Patients with other primary malignancies except cured of non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia;
• Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
• 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;
• Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery;
• 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 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);
• Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
• Patients have alcohol or drug addiction;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (4)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Henan Cancer Hospital.

Zhengzhou, Henan, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Carcinoma; Carcinoma, Squamous Cell; Esophageal Neoplasms; Neoplasms, Squamous Cell; Esophageal Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Foxiao Qiao, Ph D

CONTACT

18911165421; Foxiao_qiao@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 25, 2019
• Study Start: July 17, 2018
• Primary Completion: November 30, 2019
• Study Completion: May 31, 2020
• Last Updated: January 25, 2019

Record last verified: 2018-09

Locations

CN (4)