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Spots Global Cancer Trial Database for A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

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Trial Identification

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

Interventions

BI 905711

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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