drugset / Trial / NCT02391727

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

NCT02391727

Phase 1 Completed 10 enrolled Synermore Biologics Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribaxamase Monoclonal antibody 62.5 mg/m2 Intravenous
Subject Ribaxamase Monoclonal antibody 125 mg/m2 Intravenous
Subject Ribaxamase Monoclonal antibody 250 mg/m2 Intravenous