Overview

This trial is active, not recruiting.

Conditions phase 1 portion : non small cell lung cancer(nsclc), small cell lung cancer(sclc), mesothelioma, phase 2 portion : small cell lung cancer(sclc)
Treatment biw-8962
Phase phase 1/phase 2
Target ganglioside GM2
Sponsor Kyowa Hakko Kirin Korea Co., Ltd.
Start date July 2013
End date April 2016
Trial size 64 participants
Trial identifier NCT01898156, 8962-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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 Outcomes

Measure
Phase 1 - To determine Maximum Tolerated Dose(MTD)
time frame: 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

Secondary Outcomes

Measure
Phase 1 - To evaluate preliminary efficacy
time frame: 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 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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Kyowa Hakko Kirin Korea Co., Ltd..