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

Phase 1 – To determine Maximum Tolerated Dose(MTD) [ Time Frame: First 3-week cycle of treatment ] [ Designated as safety issue: Yes ]
Phase 1 -Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).
Phase 2 – To assess the objective response rate(Partial Response and Complete Response) [ Time Frame: Until Progressive Disease (PD) determined ] [ Designated as safety issue: Yes ]
Phase 2 – Tumor response and progression will be evaluated every 6 weeks using RECIST v 1.1. Partial Response (PR) or Complete Response (CR) will be confirmed 4 weeks after first detection of response.

Phase 1 – To evaluate preliminary efficacy [ Time Frame: Until Progressive Disease (PD) determined ] [ Designated as safety issue: No ]
Phase 1 – Tumor response progression will be evaluated using RECIST V1.1 for the assessment of efficacy
Pase 1 – To determine the q3w pharmacokinetic profile of BIW-8962 [ Time Frame: Pre-dose, and Day 1, 2, 3, 5, 8, 12 and 15 in Cycle 1 and 3, Pre-dose in Cycle 2, 4, 5,and up to Cycle 6 ] [ Designated as safety issue: No ]
Phase 1 – Pharmacokinetic (PK) parameters such as Maximum concentration (Cmax), time to maximum concentration (Tmax), minimum concentration(Cmin), area under the curve (AUC), half-life (t1/2), clearance (CL), and etc., are assessed.
Phase 2 – To assess safety and tolerance [ Time Frame: Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment ] [ Designated as safety issue: Yes ]
Phase 2 – All safety information will be collected and then evaluated.

Eligibility 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