A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

Phase 1 Completed 54 enrolled Novartis Pharmaceuticals

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This primary purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) and preferred dosing schedule of LJM716 given by IV infusion in adult patients with squamous cell carcinoma of head and neck, or esophagus, or HER2 overexpressing metastatic breast cancer or gastric cancer

Timeline

Start: 2012-07
Primary completion: 2014-03
Completion: 2014-03

Publications

Reynolds KL, Bedard PL, Lee SH, Lin CC, Tabernero J, Alsina M, Cohen E, Baselga J, Blumenschein G Jr, Graham DM, Garrido-Laguna I, Juric D, Sharma S, Salgia R, Seroutou A, Tian X, Fernandez R, Morozov A, Sheng Q, Ramkumar T, Zubel A, Bang YJ. A phase I open-label dose-escalation study of the anti-HER3 monoclonal antibody LJM716 in patients with advanced squamous cell carcinoma of the esophagus or head and neck and HER2-overexpressing breast or gastric cancer. BMC Cancer. 2017 Sep 12;17(1):646. doi: 10.1186/s12885-017-3641-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ELGEMTUMAB	Monoclonal antibody	3 mg/kg	Intravenous
Subject	ELGEMTUMAB	Monoclonal antibody	20 mg/kg	Intravenous
Subject	ELGEMTUMAB	Monoclonal antibody	40 mg/kg	Intravenous

A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer

Summary

Timeline

Publications

Drugs

Indications