Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours

Summary

This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.

Timeline

Start

2014-06-11

Primary completion

2015-07-01

Completion

2023-07-14

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper There were no dose-limiting toxicities at any dose; the MTD of xentuzumab was not reached. PMID 34870878 ↗

Publications

• Doi T, Kuboki Y, Naito Y, Ishida M, Tanaka T, Takeuchi Y. A phase 1 trial of xentuzumab, an IGF-neutralizing antibody, in Japanese patients with advanced solid tumors. Cancer Sci. 2022 Mar;113(3):1010-1017. doi: 10.1111/cas.15231. Epub 2022 Jan 13.

Drugs

Indications