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

NCT03692520 | Unknown Phase 1

• 1 other identifier: SCT200-X101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 solid tumors treated after failure of standard therapy.

Conditions

Advanced Solid Tumors

Keywords

Neoplasms; Solid Tumors; 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.

  1 year

Secondary Outcomes (4)

• Adverse events (AEs)

  1 year

• Progress Free Survival ( PFS)

  1 year

• Disease control rate (DCR)

  1 year

• Overall survival (OS)

  1 year

Study Arms (1)

SCT200

EXPERIMENTAL

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

Biological: SCT200

Interventions

SCT200 BIOLOGICAL

Recombinant Anti-EGFR Monoclonal Antibody （SCT200）

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:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• jianming xu, MD

  307 Hospital of PLA

  PRINCIPAL INVESTIGATOR

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: September 29, 2018
• First Posted: October 2, 2018
• Study Start: September 30, 2018
• Primary Completion: November 30, 2019
• Study Completion: April 30, 2020
• Last Updated: October 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)