Safety and Efficacy of SCT200 in Head and Neck Squamous Cell Carcinoma

NCT03713372 | Unknown Phase 2

• 2 other identifiers: SCT200R/MHNSCCIICTR20181541
• Study Type: interventional
• Target: 40
• 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 Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma after failure of platinum-based therapy.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; 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 (6)

• Disease control rate (DCR)

  1 year

• Progresssion free survival(PFS)

  1 year

• Overall survival(OS)

  1 year

• Immunogenicity

  1 year

• EORTC QLQ-C30

  1 year

Study Arms (1)

Anti-EGFR monoclonal antibody

EXPERIMENTAL

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.

Drug: Anti-EGFR monoclonal antibody

Interventions

Anti-EGFR monoclonal antibody DRUG

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.

Also known as: SCT200

Anti-EGFR monoclonal antibody

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate in this clinical trial and sign an informed consent form;
• Male or female, age ≥ 18 and ≤ 75 years old;
• The estimated survival period is ≥ 3 months;
• ECOG fitness status score 0 to 1;
• Recurrent and/or metastatic HNSCC (except nasopharyngeal carcinoma) diagnosed by pathology and unable to receive topical treatment (surgery or radiotherapy);
• Patients who have been treated with platinum (cisplatin/carboplatin/nidaplatin) and have clear disease progression during treatment (at least 2 cycles) or after treatment (see RECIST version 1.1) or side effects Intolerance, and the minimum dose of platinum drugs must meet:
• Minimum dose of cisplatin: ≥60mg/m2 per cycle, or ≥120mg/m2 in 8 weeks;
• The minimum dose of carboplatin: AUC ≥ 4 / cycle, or total AUC ≥ 8 within 8 weeks.
• If cisplatin is converted to platinum, the platinum dosage can be calculated using the following formula: carboplatin 1AUC = cisplatin 15mg/m2;
• The minimum dose of nedaplatin: ≥80mg/m2 per cycle, or ≥160mg/m2 in 8 weeks; Note: Platinum drugs can be used as adjuvant therapy for postoperative patients (synchronous radiotherapy), for palliative chemotherapy in patients with advanced stage or in patients with recurrent and/or metastatic disease.
• Laboratory inspection:
• Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L;
• Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 1.5;
• Renal function: creatinine (Cr) ≤ normal upper limit × 1.5;
• Electrolyte: Magnesium ≥ normal lower limit;

You may not qualify if:

• Patients with a history of central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, imaging confirmation must be performed within 28 days prior to enrollment to exclude central nervous system metastasis;
• There are other medical history of malignant tumors, except that the malignant lesions have been treated with therapeutic measures 5 years or more before enrollment and there are no known active lesions. The investigator judges that the risk of recurrence is low; Non-melanoma skin cancer, and no evidence of worsening disease; adequately treated cervical cancer in situ, and no evidence of worsening disease; prostatic intraepithelial neoplasia, no evidence of prostate cancer recurrence;
• known to be allergic to antibodies or other components contained in the test drug;
• have received EGFR antibodies (such as panitumumab, cetuximab or its analogs), or small molecule EGFR inhibitors (such as gefitinib, erlotinib, lapatinib, etc.);
• In the 4 weeks or 4 weeks before enrollment, they received anti-tumor drugs (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) or received research drug treatment and could not be included in the evaluation by the investigator. Pain-free palliative radiotherapy for bones;
• At the time of enrollment, patients still had ≥2 toxic side effects (except for hair loss, hearing loss, tinnitus, dry mouth or platinum-induced grade 2 neurotoxicity) caused by previous anti-tumor treatment;
• Patients have been enrolled in other study devices or study drug studies at screening time, or have been deactivated for less than or equal to 4 weeks from other study drugs or study devices;
• Conduct or plan major surgery within 4 weeks prior to enrollment;
• Received transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to enrollment;
• Clinically significant cardiovascular disease (defined as: unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] ≥ II), uncontrollable severe arrhythmia);
• Myocardial infarction occurred within 6 months prior to enrollment;
• History of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
• have clinical symptoms, require clinical intervention or serous effusion (such as pleural effusion and ascites) with a stabilization time of less than 4 weeks;
• medical or psychiatric history or laboratory abnormal medical history that may interfere with the interpretation of the results;
• Patients who are pregnant or breast-feeding, or who plan to be pregnant during the treatment period and within 6 months after the end of treatment;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer hospital Chinese academy of medical sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• yuankai shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 19, 2018
• Study Start: November 28, 2018
• Primary Completion: February 11, 2020
• Study Completion: May 28, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)