Clinical trial NCT03817567: Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma
Official title: Phase Ib, Open-label, Single-arm, Multicenter Study to Evaluate Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma Progressed Following Treatment With Taxane/Platinum/Fluorouracil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Squamous Cell
Esophageal Diseases
Epidermal growth factor receptor
EGFR
SCT200
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2019-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a open label, single-arm multicenter phase Ib study,and is designed to evaluate Objective Response Rate (ORR) in advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil treated with anti-EGFR monoclonal antibody SCT200.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;
* Patients with serious abnormal medical, psychological or laboratory results history which may affect explanation of study results;
* Subjects are considered not suitable for the study by investigator,who have other conditions that may affect their adherence and the evaluation of study indicators.,

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: one year
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: one year
measure: PFS
timeFrame: one year
measure: Duration of response (DOR)
timeFrame: one year
measure: Overall survival (OS)
timeFrame: one year
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital.
state: Henan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: