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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598077
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

May 4, 2012
May 15, 2012
April 23, 2014
July 2012
March 2014   (Final data collection date for primary outcome measure)
Dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT01598077 on Archive Site
  • Adverse events [ Time Frame: 4 months ]
  • Serious adverse events [ Time Frame: 4 months ]
  • Pharmacodynamic response to LJM716 in tumor tissue [ Time Frame: 3 months ]
  • Frequency of partial responses, complete responses and stable disease according to RECIST [ Time Frame: every 2 months ]
  • Serum concentration of antibodies to LJM716 [ Time Frame: 18 months ]
  • Progression-free survival [ Time Frame: 18 months ]
  • Duration of response [ Time Frame: 18 months ]
  • Serum concentration of LJM716, [ Time Frame: 4 months ]
Same as current
Not Provided
Not Provided
A Phase I Study of LJM716 in Squamous Cell Carcinoma of Head and Neck, or HER2+ Breast Cancer or Gastric Cancer
A Phase I Study of LJM716 in Patients With Squamous Cell Carcinoma of Head and Neck, or HER2 Overexpressing Metastatic Breast Cancer or Gastric Cancer
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
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma
  • HER2 + Breast Cancer
  • HER2 + Gastric Cancer
  • Squamous Cell Carcinoma of Head and Neck
  • Esophageal Squamous Cell Carcinoma
Drug: LJM716
Experimental: Dose escalation and dose expansion
Intervention: Drug: LJM716
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck, or esophageal squamous cell carcinoma
  • Site of disease that can be safely biopsied

Exclusion criteria:

  • Patients received prior anti-HER3 antibody treatment
  • Patients with impaired cardiac function
  • Brain metastases that have not been adequately treated
  • Malignant disease other than that being treated in this study
  • Pregnant or nursing (lactating) women
  • Laboratory abnormalities as specified in the protocol Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   Korea, Republic of,   Spain,   Taiwan,   United States
2011-004865-33 ( EudraCT Number )
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP