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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01898156
Recruitment Status : Terminated (lack of efficacy)
First Posted : July 12, 2013
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):
Kyowa Hakko Kirin Korea Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma Phase 2 Portion : Small Cell Lung Cancer(SCLC) Drug: BIW-8962 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Advanced/Recurrent Lung Cancer or Mesothelioma
Study Start Date : July 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIW-8962

Phase 1 - Dose escalation based on the BIW-8962 tolerability and safety data obtained from three subjects enrolled in a cohort (first cycle of treatment), enrollment at the next dose level or additional subjects into the ongoing cohort will occur

Phase 2 - Recommended dose determined in Phase 1

Drug: BIW-8962

Phase 1 -With a standard 3+3 dose escalation design, the enrollment in Phase 1 will proceed until the MTD has been defined or the highest dose level has been reached. BIW-8962 will be administered intravenously on day 1 of each 21 day cycle.

Phase 2 - RP2D of BIW-8962 determined in phase 1 portion will be administered until progression or unacceptable toxicity develops.

Primary Outcome Measures :
  1. Phase 1 - To determine Maximum Tolerated Dose(MTD) [ Time Frame: First 3-week cycle of treatment ]
    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).

  2. Phase 2 - To assess the objective response rate(Partial Response and Complete Response) [ Time Frame: Until Progressive Disease (PD) determined ]
    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 :
  1. Phase 1 - To evaluate preliminary efficacy [ Time Frame: Until Progressive Disease (PD) determined ]
    Phase 1 - Tumor response progression will be evaluated using RECIST V1.1 for the assessment of efficacy

  2. Phase 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 ]
    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.

  3. 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 ]
    Phase 2 - All safety information will be collected and then evaluated.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01898156

Korea, Republic of
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Kyowa Hakko Kirin Korea Co., Ltd.

Responsible Party: Kyowa Hakko Kirin Korea Co., Ltd. Identifier: NCT01898156     History of Changes
Other Study ID Numbers: 8962-002
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial