NCT03972150

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

An Open Label, Phase I Study of BI 836880 Monotherapy and Combination Therapy of BI 836880 and BI 754091 in Japanese Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	BI 836880	Solution for infusion
DRUG	BI 754091	Solution for infusion

Timeline

• Start date: 2019-06-12
• Primary completion: 2020-10-27
• Completion: 2022-03-28
• First posted: 2019-06-03
• Last updated: 2025-10-06
• Results posted: 2025-10-06

Locations

2 sites across 1 country: Japan