A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer

Summary

The primary objective of this trial is: Part I * To determine Maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BI 836880 monotherapy Part II * To determine MTD and/or RP2D of the combination therapy of BI 836880 and BI 754091 The secondary objectives are: Part I * To document the safety and tolerability, and characterise pharmacokinetics (PK) of BI 836880 as monotherapy Part II * To document the safety and tolerability, and characterise PK of the combination therapy of BI 836880 and BI 754091

Timeline

Start

2019-06-12

Primary completion

2020-10-27

Completion

2022-03-28

Publications

• Yamamoto N, Koyama T, Shimizu T, Todaka A, Kawakami T, Erzen D, Sarashina A, Li B, Hou J, Yamazaki K. Phase I study of the VEGF/Ang-2 inhibitor BI 836880 alone or combined with the anti-programmed cell death protein-1 antibody ezabenlimab in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2023 Jun;91(6):469-480. doi: 10.1007/s00280-023-04527-6. Epub 2023 May 4.

Drugs

Indications