NCT04137289

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1a - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3). Phase 1a - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD. Phase 1b - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

Conditions

• Gastrointestinal Neoplasms
• Cholangiocarcinoma
• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	BI 905711	BI 905711

Timeline

• Start date: 2020-03-11
• Primary completion: 2023-07-26
• Completion: 2023-11-27
• First posted: 2019-10-24
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

18 sites across 8 countries: United States, Belgium, China, France, Germany, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study