From the blog

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

Published: July 2, 2014


Primary Outcome Measure:

  • 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.

Secondary Outcome Measures:

  • 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
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