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

December 13, 2016 updated by: Kyowa Kirin Korea Co., Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
First 3-week cycle of treatment
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.
Until Progressive Disease (PD) determined

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until Progressive Disease (PD) determined
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.
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 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.
Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Korea Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8962-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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