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

Primary Purpose

Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma, Phase 2 Portion : Small Cell Lung Cancer(SCLC)

Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BIW-8962
Sponsored by
Kyowa Kirin Korea Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIW-8962

Arm Description

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

Outcomes

Primary Outcome Measures

Phase 1 - To determine Maximum Tolerated Dose(MTD)
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)
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
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
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
Phase 2 - All safety information will be collected and then evaluated.

Full Information

First Posted
June 18, 2013
Last Updated
December 13, 2016
Sponsor
Kyowa Kirin Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01898156
Brief Title
Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of efficacy
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Korea Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma, Phase 2 Portion : Small Cell Lung Cancer(SCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIW-8962
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
BIW-8962
Intervention Description
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 Measure Information:
Title
Phase 1 - To determine Maximum Tolerated Dose(MTD)
Description
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).
Time Frame
First 3-week cycle of treatment
Title
Phase 2 - To assess the objective response rate(Partial Response and Complete Response)
Description
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.
Time Frame
Until Progressive Disease (PD) determined
Secondary Outcome Measure Information:
Title
Phase 1 - To evaluate preliminary efficacy
Description
Phase 1 - Tumor response progression will be evaluated using RECIST V1.1 for the assessment of efficacy
Time Frame
Until Progressive Disease (PD) determined
Title
Phase 1 - To determine the q3w pharmacokinetic profile of BIW-8962
Description
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.
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
Title
Phase 2 - To assess safety and tolerance
Description
Phase 2 - All safety information will be collected and then evaluated.
Time Frame
Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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