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Brief Title: A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer
Official Title: A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers
Study ID: NCT04137289
Brief 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)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Yale Cancer Center, New Haven, Connecticut, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
START South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Brussels - UNIV Saint-Luc, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Beijing Cancer Hospital, Beijing, , China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China
HOP Jean Minjoz, Besançon, , France
CTR Leon Berard, Lyon, , France
HOP la Milétrie, Poitiers, , France
CTR Eugène Marquis, Rennes, , France
Universitätsklinikum Mannheim GmbH, Mannheim, , Germany
National Cancer Center Hospital East, Chiba, Kashiwa, , Japan
Korea University Anam Hospital, Seoul, , Korea, Republic of
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Clínico de Valencia, Valencia, , Spain