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

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01598077 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:


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


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Jose Baselga M.D., Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion criteria: - Patients with HER2+ breast cancer, or HER2+ gastric cancer, or squamous cell carcinoma of head and neck - Site of disease that can be safely biopsied Exclusion criteria: - Patients received prior anti-HER3 antibody treatment - Patient's tumor displays no indication of HER3 pathway activation - 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
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