Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma - Phase 2 Portion : Small Cell Lung Cancer(SCLC)
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Mesothelioma - Small Cell Lung Carcinoma
Study Type
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: BIW-8962
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea
Seoul, Korea, Republic of
Status: Recruiting
Start Date
July 2013
Completion Date
April 2016
Kyowa Hakko Kirin Korea Co., Ltd.
Kyowa Hakko Kirin Korea Co., Ltd.
Record processing date processed this data on July 28, 2015 page