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

NCT ID: NCT02211443

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief Summary

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

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Two phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody:

First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg

Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups.

Group Type: EXPERIMENTAL

Recombinant full human Anti-EGFR Monoclonal Antibody

Intervention Type: BIOLOGICAL

Interventions

Recombinant full human Anti-EGFR Monoclonal Antibody

Intervention Type: BIOLOGICAL

Other Intervention Names

SCT200

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Zhang W, Han X, Yang L, Song Y, Xie L, Gai W, Wang Y, Shi Y. Safety, pharmacokinetics and efficacy of SCT200, an anti-EGFR monoclonal antibody in patients with wild-type KRAS/NRAS/BRAF metastatic colorectal cancer: a phase I dose-escalation and dose-expansion study. BMC Cancer. 2022 Oct 28;22(1):1104. doi: 10.1186/s12885-022-10147-9.

Reference Type: DERIVED

PMID: 36307775 (View on PubMed)

Other Identifiers

SCT200mCRCI

Identifier Type: -

Identifier Source: org_study_id