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Safety, Immunogenicity and Pharmacokinetics of SYN004 in Patients With Solid Tumors

NCT02391727 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-16

No results posted yet for this study

Summary

A first-in-human evaluation of SYN004, a monoclonal antibody that binds to the EGF receptor on cancer cells. Cetuximab, a marketed antibody, has been shown to be effective by inhibiting the growth of cancer cells thereby prolonging the life of patients who have received it. SYN004 is a closely related monoclonal antibody also binds to the EGF receptor in the same way. SYN004 might also inhibit cancer cells and prolong life but has been engineered to avoid some of the hypersensitivity reactions known to provoked by cetuximab.

Conditions

  • Colon Cancer, Breast Cancer, Cancer of the Head and Neck

Interventions

BIOLOGICAL

SYN004

subjects who have received effective treatment for their cancers are eligible

Sponsors & Collaborators

  • Synermore Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • John McClain, MD · Synermore Biologics Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United States

Study Locations

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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 NCT02391727 on ClinicalTrials.gov