Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Korea Co., Ltd.; Kyowa Kirin Korea Co., Ltd.

Criteria

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