A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer

NCT03356158 | Unknown Phase 1

• 1 other identifier: CPGJ602-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, parallel designed study to assess the pharmacokinetics, safety and tolerability of the single-dose and multi-dose of a recombinant anti-EGFR monoclonal antibody (CPGJ602) in patients with at least one prior chemical regimen failed metastatic colorectal cancer. The immunogenicity and preliminary efficacy of CPGJ602 will also be assessed. The study includes 3 parts: part 1: after a single dose of CPGJ602 or cetuximab (the active comparator), the patients will be observed for 4 weeks; part 2: CPGJ602 or cetuximab will be administered to the patients once a week for 5 weeks; part 3: CPGJ602 will be administered to the patients once a week until the patient's death or the withdrawal decision of the patient and/or investigator.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer,; Recombinant Anti-EGFR Monoclonal Antibody

Outcome Measures

Primary Outcomes (4)

• Maximum Plasma Concentration [Cmax]

  part 1 for single dose and part 2 for multiple doses

  Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses

• Half life of CPGJ602 in blood [t1/2]

  part 1 for single dose and part 2 for multiple doses

  Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses

• Area Under the Curve [AUC]

  part 1 for single dose and part 2 for multiple doses

  Day 0 - Day 21 for single dose and Day 28 - Day 63 for multiple doses

• Incidence of Adverse Events [AEs]

  to evaluate the safety and tolerability

  Day -28 to 1 month following the last administration

Secondary Outcomes (4)

• Anti-Drug Antibody [ADA]

  Day 0 to Day 63, and in the follow-up period.

• Objective Response Rate [ORR]

  Day -28 - Day 63

• Carcinoembryonic antigen [CEA]

  Day -28 - Day 63

• Cancer antigen [CA19-9]

  Day -28 - Day 63

Study Arms (3)

CPGJ 602 low dose

EXPERIMENTAL

Part 1: CPGJ602, IV over 2 hours, 100 mg/m2 X 1;

Biological: CPGJ602

CPGJ 602 normal dose

EXPERIMENTAL

Part 1: CPGJ602, IV over 2 hours, 400 mg/m2 X 1; Part 2: CPGJ602, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time;

Biological: CPGJ602

Cetuximab normal dose

ACTIVE COMPARATOR

Part 1: Cetuximab, IV over 2 hours, 400 mg/m2 X 1. Part 2: Cetuximab, IV, QW, 400 mg/m2 X 1, over 2 hours, followed by 250mg/m2 X4, over 1 hour for each time.

Biological: Cetuximab

Interventions

CPGJ602 BIOLOGICAL

Injection, q.w., 20 mg: 100 ml

CPGJ 602 low dose; CPGJ 602 normal dose

Cetuximab BIOLOGICAL

Injection, q.w., 20 mg: 100 ml

Cetuximab normal dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female.
• Histologically or cytologically confirmed metastatic CRC, and have failed (disease progression or intolerance) at least one prior chemical regimen containing oxaliplatin, irinotecan or 5-FU, etc.
• ECOG performance status 0 or 1.
• Estimated life expectancy ≥ 3 months.
• RAS (including K-ras and N-ras) wide type status.
• Adequate bone marrow, hepatic and renal functions. Hematopoietic:
• Leukocytes (WBC)\>4.0×109/L or Absolute Neutrophil Count (ANC)\> 1.5×109/L, Platelet Count (PLT)\>80×109/L, Hemoglobin (Hb)\>90g/ L; Hepatic: Total Bilirubin (T-Bil)≤1.5×ULT (Upper Limit of Normal), Alanine Transaminase (ALT)/ Aspartate Transaminase (AST)≤2.5×ULT or ≤5×ULT in case of liver metastases; Renal: Blood Urea Nitrogen (BUN)≤1.5×ULT, Serum Creatinine (Cr) ≤ 1.5×ULT.
• At least one measurable disease based on RECIST criteria (v 1.1).
• Signed informed consent on a voluntary basis at screening, and no geographical condition that would preclude the study compliance.

You may not qualify if:

• Less than 28 days since prior chemotherapy, radiotherapy or surgery (diagnosis biopsy is allowed).
• Previous epidermal growth factor receptor (EGFR) targeted therapies (including monoclonal antibody, tyrosine kinase inhibitor \[TKI\] and other EGFR targeted therapies, such as cetuximab, nimotuzumab, panitumumab, gefitinib, erlotinib, and icotinib, etc.
• Known hypersensitivity to study drugs or any of the excipients.
• Known or clinical suspected brain metastases and/or disease of meninges.
• Clinically significant cardiovascular or cerebrovascular dis ease, history of myocardial infarction (MI) in the latest 6 months, or high-risk of uncontrolled cardiac arrhythmias.
• History of acute or sub-acute intestinal obstruction, or of inflammatory bowel disease.
• A serious and uncontrolled concomitant disease which, in the investigator's opinion, rules out the patient's participation in the study, such as history of malignancies other than CRC (with the exception of: curatively treated carcinoma of the skin \[except for melanoma\]; cured cervical cancer or basal cell skin cancer, ductal carcinoma in situ \[DICS\], endometrial carcinoma \[stage I grade 1\]; and other solid tumors including lymphoma without bone marrow infiltration for which the patient has been disease-free for 5 years), uncontrolled hypertension, diabetes mellitus (DM), peripheral neuropathy, and infectious diseases (including viral, bacterial and parasitic infections), etc.
• Pregnancy or lactation, or a fertility plan during the participation in this study.
• No more than 4 weeks or no more than 5 times of t1/2 since prior investigational agents.
• Other situations that impede the patient's participation in the study at the discretion of the investigator.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310020, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jianming Xu, Doctor

  the Afflicated Hospital of Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanrui Wu, Master

CONTACT

13601126093; wuquanrui@3sbio.com

Study Design

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

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 29, 2017
• Study Start: November 15, 2017
• Primary Completion: October 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 17, 2018

Record last verified: 2017-11

Locations

CN (1)