Phase
Condition
Pancreatic Cancer
Stomach Cancer
Colorectal Cancer
Treatment
BI 765049
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Signed and dated informed consent form (ICF)2/main ICF for all patients describingthe study in accordance with International Council on Harmonisation Good ClinicalPractice (ICH-GCP) and local legislation prior to any trial-specific procedures,sampling, or analyses.
Patient must be ≥18 years of age and at least at the legal age of consent incountries where it is greater than 18 years at the time of signature on the ICFs (ICF1/screening ICF and ICF2/main ICF).
In US: Patients with a histologically or cytologically confirmed diagnosis ofcolorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductaladenocarcinoma (PDAC).
In Europe: Patients with a histologically or cytologically confirmed diagnosis ofCRC.
Patients with advanced, unresectable, and/or metastatic disease. Further inclusioncriteria apply.
Exclusion
Exclusion criteria:
Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and/or Medical Monitor's assessment).
Previous or concomitant malignancies other than the one treated in this trial withinthe last 5 years except:
Effectively treated non-melanoma skin cancers
Effectively treated carcinoma in situ of the cervix
Effectively treated ductal carcinoma in situ
Other effectively treated malignancy that is considered cured by localtreatment"
Patient with known leptomeningeal disease or spinal cord compression due to disease.
Patient requiring anticoagulant treatment which cannot be safely interrupted, ifmedically needed for a study procedure (e.g. biopsy) based on the opinion of theInvestigator.
Further exclusion criteria apply.
Study Design
Connect with a study center
Charite Universitätsmedizin Berlin KöR
Berlin, 10117
GermanySite Not Available
Katholisches Klinikum Bochum gGmbH
Bochum, 44791
GermanySite Not Available
Technische Universität Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
GermanySite Not Available
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
GermanySite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Clínico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Virgen de la Victoria
Málaga, 29010
SpainSite Not Available
Hospital Clínico de Valencia
Valencia, 46010
SpainSite Not Available
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06520
United StatesSite Not Available
Winship Cancer Institute
Atlanta, Georgia 30322
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
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