LJM716 combination with trastuzumab in HER2+ Metastatic Breast Cancer
Research type
Research Study
Full title
A multicenter, open-label, dose escalation, Phase I study of LJM716 administered intravenously in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer.
IRAS ID
105806
Contact name
Anthony Kong
Contact email
Sponsor organisation
Novartis Pharmaceuticals
Eudract number
2011-004881-13
Duration of Study in the UK
1 years, 10 months, 17 days
Research summary
This is a Phase I, First In Man Study with the experimental drug LJM716, divided into 2 phases dose escalation and dose expansion phase.
The goal of the Phase I - dose escalation study is to establish a safe dose range based on side effects of LJM716 the study drug. The goal of the dose expansion will evaluate how well the study drug combination might work in treating metastatic breast cancer (MBC).
The medicine being tested in this study is LJM716 a new type of drug which keeps the HER3 protein receptor inactivated (indicated to inhibit tumour growth) by binding to it and also inhibiting HER2 receptor binding and activation of the HER3 receptor. Trastuzumab (Herceptin®) - The other study drug trastuzumab is a medicine already
approved for the treatment of various cancers, and is already widely used worldwide to treat patients with advanced or metastatic breast cancer.
Both LJM716 and trastuzumab, will be given intravenously, once a week. Trastuzumab will always be administered before LJM716. As LJM716 inhibits HER3 amplification, which has been implicated in making patients resistant to trastuzumab and trastuzumab inhibits HER2 amplification , by combining them, it might be possible to slow the progression of the tumours rather than if each treatment was given separately and also trastuzumab resistance may be reversed with the combination.
So far, LJM716 has been tested extensively in the laboratory but has not been tested in humans. At least 35 patients (only women) with metastatic breast cancer will join in this study (at least 15 patients will participate in the dose escalation part of the study and at least 20 patients will participate in the dose expansion)
This trial is sponsored by the pharmaceutical company named Novartis.REC name
South Central - Oxford B Research Ethics Committee
REC reference
12/SC/0314
Date of REC Opinion
27 Jun 2012
REC opinion
Further Information Favourable Opinion