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

NCT02211443 | Unknown Phase 1

• 1 other identifier: SCT200mCRCI
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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

Keywords

Full human anti-EGFR monoclonal antibody (SCT200) ;; metastatic colorectal cancer （mCRC）;; Escalating doses ;; single dose and multiple doses;; safety, tolerability and pharmacokinetics.

Outcome Measures

Primary Outcomes (1)

• Number of participants with SCT200-related adverse events

  up to 105 days

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• Time to Disease Progression (TTP) of SCT200

  up to 105 days

Study Arms (1)

Single arm

EXPERIMENTAL

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.

Biological: Recombinant full human Anti-EGFR Monoclonal Antibody

Interventions

Recombinant full human Anti-EGFR Monoclonal Antibody BIOLOGICAL

Also known as: SCT200

Single arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Related Publications (1)

• 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.

  PMID: 36307775 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Design

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

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 7, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04