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

Inclusion criteria

• Patients with confirmed HER-2 positive, metastatic or non-operable locally advanced breast or gastric cancer
• Metastatic breast cancer patients must have received a minimum of 1 and a maximum of 3 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab, ado-trastuzumab emtansine or lapatinib
• Metastatic gastric cancer patients must have received a minimum of 1 and a maximum of 2 prior anti HER2 based regimens with documented progression on the most recent regimen which must contain trastuzumab or ado-trastuzumab emtansine
• During the dose expansion part of study, all patients must have at least one measurable lesion as defined by RECIST criteria.
• Patients must have at least one prior 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 or any investigational therapy within 4 weeks or within 5 half- lives of the therapy prior to starting study treatment, whichever is shorter, or for cyclical therapy, within one cycle length (e.g. 6 weeks for nitrosourea, mitomycin-C).
• 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 readily obtainable.

Other protocol-defined inclusion/exclusion criteria may apply