Dose-escalation Study of Lupartumab Amadotin (BAY1129980)

Summary

The purpose of this study is to evaluate: * The side effects of BAY1129980 when given every 21 days different dose levels. * Determine the dose level of BAY1129980 that should be tested in future clinical research studies. * Measure how much BAY1129980 is in the blood at specific times after administration. * If treatment with BAY1129980 shows any effect on reducing the tumor growth. * If there are specific biomarkers that might be able to explain why some patients respond to treatment and others do not. * If treatment with BAY1129980 causes an immune response from the body against the drug (immunogenicity).

Timeline

Start

2014-05-22

Primary completion

2018-08-30

Completion

2018-08-30

Publications

• Willuda J, Linden L, Lerchen HG, Kopitz C, Stelte-Ludwig B, Pena C, Lange C, Golfier S, Kneip C, Carrigan PE, Mclean K, Schuhmacher J, von Ahsen O, Muller J, Dittmer F, Beier R, El Sheikh S, Tebbe J, Leder G, Apeler H, Jautelat R, Ziegelbauer K, Kreft B. Preclinical Antitumor Efficacy of BAY 1129980-a Novel Auristatin-Based Anti-C4.4A (LYPD3) Antibody-Drug Conjugate for the Treatment of Non-Small Cell Lung Cancer. Mol Cancer Ther. 2017 May;16(5):893-904. doi: 10.1158/1535-7163.MCT-16-0474. Epub 2017 Mar 14.

Drugs

Indications