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

Completed · Phase 1

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT01598077

Run by

Novartis Pharmaceuticals

People needed

54

Starts

2012-07-01

Expected to finish

2014-03-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Chicago Medical Center University of Chicago (16) — Chicago, Illinois, United States
• Massachusetts General Hospital SC-5 — Boston, Massachusetts, United States
• University of Texas/MD Anderson Cancer Center UT MD — Houston, Texas, United States
• University of Utah / Huntsman Cancer Institute Huntsman — Salt Lake City, Utah, United States
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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