Study of ISU104, Targeting ERBB3 in Patients With Advanced Solid Tumors

Phase 1 Unknown 33 enrolled ISU Abxis Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

A phase I, open-label, dose-finding study to assess the safety, tolerability and pharmacokinetics of ISU104, a human monoclonal antibody targeting erbB3 in patients with advanced solid tumors.

Timeline

Start: 2018-04-27
Primary completion: 2020-10-19
Completion: 2021-12-31

Publications

Seo S, Keam B, Shin SH, Chae YS, Kim TM, Park LC, Hong SB, Ahn MJ, Kim SB. A phase Ia/Ib study of novel anti-ErbB3 monoclonal antibody, barecetamab (ISU104) in refractory solid cancers and monotherapy or in combination with cetuximab in recurrent or metastatic head and neck cancer. Int J Cancer. 2023 Oct 15;153(8):1501-1511. doi: 10.1002/ijc.34622. Epub 2023 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	barecetamab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	barecetamab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	barecetamab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	barecetamab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	barecetamab	Monoclonal antibody	20 mg/kg	Intravenous

Study of ISU104, Targeting ERBB3 in Patients With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications