A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
Phase Ia - 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 Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination
of a potentially effective dose range for phase Ib in the absence of MTD.
Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range
and determine the Recommended Phase 2 Dose (RP2D)