drugset / Trial / NCT01898156

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

NCT01898156 ↗

Phase 1/2 Terminated 37 enrolled Kyowa Kirin Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-07
Primary completion
2016-06
Completion
2016-06

Outcome

Outcome not reported

Stopped: “lack of efficacy”

Drugs

EvaluationDrugModalityDoseRoute
Subject BIW-8962 Monoclonal antibody — Intravenous