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

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