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COMPLETED
NCT03017807
PHASE1

Safety and Pharmacokinetics of Recombinant Anti-EGFr Antibody in Patients With Metastatic Colorectal Cancer

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

A single-central,open-label,safety,pharmacokinetics,phase I study. Biological:Recombinant Anti-EGFr Antibody Two dose levels: Low-dose level patients received initial dose 100 mg/m2 and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.High-dose level patients received cetuximab initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.

Official title: A PhaseⅠ,Open-label, Single-center Study to Evaluate Safety and Pharmacokinetics of Recombinant Anti-Epidermal Growth Factor Receptor (EGFr) Antibody in Patients With Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2016-12-30

Completion Date

2018-01-22

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Recombinant Anti-EGFr Antibody

Low-dose level patients received cetuximab initial dose 100 mg/m2 and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.High-dose level patients received cetuximab initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.

Locations (1)

Sichuan Kelun Pharmaceutical Co., Ltd.

Chengdu, China