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

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

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

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

• NCT number: NCT01898156
• Study type: Interventional
• Source: Kyowa Kirin Co., Ltd.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 2013
• Completion date: June 2016