Safety, Tolerability and Pharmacokinetics of Recombinant Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody in Patients With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody，in Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02211443
• Other study ID #: SCT200mCRCI
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: August 5, 2014
• Last updated: April 8, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether SCT200 is safe and tolerant in the treatment of metastatic colorectal cancer

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 21
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged from 18 to 70 years;

• having histologically confirmed metastatic colorectal cancer;

• having experienced previous treatment failures including fluoropyrimidine, irinotecan and oxaliplatine chemotherapy regiment;

• having determined wild-type KRAS tumor;

• having to have measurable or nonmeasurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected survival of at least =3 months;

• adequate hematological, renal and liver functions:

1. Hematological function: white blood cell count of >4.0×109/L; absolute neutrophil count of >1.5×109/ L; platelet count of >100×109/L; hemoglobin level of >90.0 g/L;

2. Renal function: serum creatinine level of<1.5×upper limit of normal (ULN);

3. Liver function: total bilirubin level of<1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of <1.5×ULN; or <5 × ULN for patients with liver metastases;

• no other malignancies only if they had following malignancies , which were not required to treat or who had curative resection: cervical carcinoma in situ, the skin basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they had some malignancies requirement only surgical therapy and disease free survival=5 years;

• no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary artery disease, and mental disorder.

• not pregnant; or not lactating; or accepted birth control methods during the study;

• signed an informed consent form which was approved by the institutional review board of the respective medical center .

Exclusion Criteria:

• had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or anti- EGFR monoclonal antibody;

• having to be at least 4 weeks beyond prior anticancer therapy (including corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or participating in other clinical trial, or have not recovered from significant toxicities of prior therapy;

• chronic use of medication that could interfere with the assessment of drug-related toxicities or immunologic activity (high dose prednisone or high dose non-steroid anti-inflammatory medication);

• had recent major surgery (within 28 days);

• with symptomatically brain metastases (with the exception of clinically brain metastases stable and of no requirement further treatment);

• with active infection requirement systemic antibiotics treatment; or serious cardiovascular disease;or with evidence of active hepatitis B or C infection; or with human immunodeficiency virus infection;

• had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic obstructive pulmonary disease (COPD) or with risk factors to COPD;

• with eye inflammation or infection, or any risk factors who could lead to eye disease;

• with a history of allergic reaction or protein product allergy including antibodies product;

• pregnant, or lactating, or not accepted birth control methods including male patients.

• had a history of alcohol or drugs addiction, or with any risk which may affect the patient's health evaluation or mantle state

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Biological:
• Recombinant full human Anti-EGFR Monoclonal Antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Disease Progression (TTP) of SCT200		up to 105 days	No
Primary	Number of participants with SCT200-related adverse events		up to 105 days	Yes
Secondary	Area Under the plasma concentration versus time curve (AUC) of SCT200		prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose	No