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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Kyowa Hakko Kirin Korea Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Korea Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01898156
First received: June 18, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention 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
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Korea Co., Ltd.:

Primary Outcome Measures:
  • 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

  • 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 ] [ 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.


Estimated Enrollment: 64
Study Start Date: July 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898156

Contacts
Contact: KYOWA HAKKO KIRIN KOREA clinical.info@kyowa-kirin.co.jp

Locations
Korea, Republic of
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea Recruiting
Seoul, Korea, Republic of
Contact: KYOWA HAKKO KIRIN KOREA         
Sponsors and Collaborators
Kyowa Hakko Kirin Korea Co., Ltd.
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Korea Co., Ltd.
ClinicalTrials.gov Identifier: NCT01898156     History of Changes
Other Study ID Numbers: 8962-002
Study First Received: June 18, 2013
Last Updated: January 28, 2014
Health Authority: Korea: Ministry of Food and Drug Safety

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

ClinicalTrials.gov processed this record on August 28, 2014