Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of BIW-8962 as Monotherapy in Subjects With Lung Cancer
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.
Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma
Phase 2 Portion : Small Cell Lung Cancer(SCLC)
|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|
- 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.
- 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.
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898156
|Korea, Republic of|
|For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Korea|
|Seoul, Korea, Republic of|