lack of efficacy

This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.

Inclusion Criteria:

• Phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent SCLC, NSCLC or mesothelioma
• Phase 2: measurable, unresectable advanced or recurrent SCLC
• A life expectancy > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
• Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ institution's established lower limit of normal
• Adequate hematologic, hepatic, renal and lung function

Exclusion Criteria:

• Subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose
• Subject received monoclonal antibodies within 4 weeks of the first dose
• Major surgery within 4 weeks prior to the first dose
• Known symptomatic brain metastases
• Clinically significant cardiovascular disease
• Leptomeningeal disease
• Uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc
• Known HIV disease or acquired immunodeficiency syndrome-related illness
• A psychiatric illness, disability or social situation
• Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins
• A history of primary brain/CNS malignancy
• Neurological paraneoplastic syndrome