MM-121 is a material called an anti-ErbB3 human monoclonal antibody. A monoclonal antibody is a type of protein made in the laboratory. Starting with an actual cell, duplicate antibody proteins are made to be exactly like the original ("monoclonal"). An antibody is a type of protein that is made in the body in response to a foreign substance. Antibodies can locate and bind to substances in the body, including tumor cells. MM-121 is an antibody that binds to a specific protein found on the surface of the cells. This protein, ErbB3, is involved with cell growth. In laboratory studies, MM-121 has been shown to bind to ErbB3 and hinder tumor cell growth. This study is going to look at the effects in humans.
In this study, MM-121 will be used in combination with a FDA approved drug called erlotinib (Tarceva). Erlotinib is approved for the treatment of non-small cell lung cancer, but not in combination with another treatment. In laboratory studies, the combination of MM-121 and erlotinib was shown to be more effective at reducing tumor size than using either drug by itself.
- Must have histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.
- Must be >18 years of age. Must have measurable disease for the phase 2 portion in accordance with RECIST v 1.1.
- Must have an ECOG Performance Score (PS) of 0, 1 or 2. Must have a lesion amenable to biopsy and must be willing to undergo a pre-treatment biopsy, unless both of the following conditions are met: Subject underwent a biopsy within 2 months prior to enrollment and has sufficient tumor tissue available and Subject has not had any intervening treatment since this biopsy.
- Subjects must have archived tumor samples available for analysis. Approximately 125 m of tumor sample is required (as FFPE blocks or prepared as slides).
- Must NOT have untreated and/or symptomatic CNS malignancies (primary or metastatic).
- Must NOT have CNS metastases who have undergone surgery or radiotherapy.