Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer

Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Metastatic
NCT ID: NCT01602406 (View complete trial on
DFCI Protocol ID:


This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.


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: - Female patients with confirmed HER-2 positive , non-operable locally advanced or metastatic breast cancer - All patients must have received at least 1 but no more than 3 prior anti HER2 based regimens including at least 1 regimen containing Trastuzumab. - All patients must have at least one measurable lesion as defined by RECIST criteria. - Patients must have documented progression on the latest treatment and the latest treatment must be a trastuzumab-containing regimen - Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 Exclusion Criteria: - Patients with Central Nervous System (CNS) metastasis which are: symptomatic or require treatment for symptom control and/or growing - Prior treatment with any anti-HER3 (Human Epidermal growth factor Receptor 3) treatment - Impaired cardiac function - Prior to the first dose of study treatment, patients who have received systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any investigational therapy within 4 weeks (< 6 weeks for nitrosourea or mitomycin-C, antibodies except for trastuzumab) or within 5-half lives of the investigational therapy prior to starting study treatment, whichever is longer - Patients who have a history of primary malignancy other than that being treated in this study, and currently requires active clinical intervention. - Patients who do not have an archival tumor sample (or sections of it) available or any tumor sample readily obtainable. Other protocol-defined inclusion/exclusion criteria may apply
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