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

Novartis

Status and phase

Completed

Phase 1

Conditions

Squamous Cell Carcinoma of Head and Neck

HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma

HER2 + Gastric Cancer

HER2 + Breast Cancer

Treatments

Drug: LJM716

Study type

Interventional

Funder types

Industry

Identifiers

NCT01598077

2011-004865-33 (EudraCT Number)

CLJM716X2101

Details and patient eligibility

About

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

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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