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Phase IIa Study of Nimotuzumab to Treat Colorectal Cancer

NCT05278728 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-02-07

No results posted yet for this study

Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Conditions

Interventions

DRUG

Nimotuzumab

200,400,600 or 800mg weekly until progression or AEs

DRUG

Irinotecan

180mg/m2 d1, Q2w until progression or AEs or maximum 6 cycles

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    lead OTHER

Principal Investigators

  • Lin Shen · Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-08-31
Completion
2013-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05278728 on ClinicalTrials.gov