Phase
Condition
Lung Disease
Nasopharyngeal Cancer
Liver Cancer
Treatment
Ezabenlimab
BI 765049
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated, written inform consent form (ICF) (ICF1 for B7-H6 testing for allpatients except those with colorectal cancer (CRC); ICF2 for all patients)describing the study in accordance with International Council on Harmonisation GoodClinical Practice (ICH-GCP) and local legislation prior to any trial-specificprocedures, sampling, or analyses.
≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).
Histologically or cytologically confirmed diagnosis of an advanced, unresectable,and/or metastatic gastrointestinal cancer, colorectal cancer, pancreatic cancer,liver cancer, head and neck cancer, or lung cancer.
Disease progression despite conventional treatment, intolerant to or not a candidatefor conventional treatment, or with a tumour for which no conventional treatmentexists.
Agree to the collection of tumour samples (as slides from archival diagnosticsamples or fresh tumour biopsies) for confirmation of B7-H6 expression at ScreeningVisit 02 for colorectal cancer (CRC) patients or at Screening Visit 01 for all otherpatients.
Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy)based on central pathology review except for patients diagnosed with advanced ormetastatic colorectal cancer (CRC).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
At least one evaluable target lesion as defined per response evaluation criteria insolid tumors (RECIST v1.1), outside of the central nervous system (CNS), separatefrom any lesion(s) identified for tumour biopsy. Tumour lesions that have beenirradiated ≥28 days before the start of treatment, and have subsequently haddocumented progression, may be chosen as target lesions only in the absence ofmeasurable lesions that have not been irradiated.
Further inclusion criteria apply
Exclusion
Exclusion Criteria:
History of a major surgery within 28 days prior to first dose of BI 765049 (majoraccording to the Investigator's assessment).
Previous or concomitant malignancies other than the one treated in this trial withinthe last 3 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
Known leptomeningeal disease or spinal cord compression due to disease.
Require anticoagulant treatment which cannot be safely interrupted, if medicallyneeded for a study procedure (e.g., biopsy) based on the opinion of theInvestigator.
Hepatitis C virus (HCV) infection, defined as:
Currently receiving curative antiviral treatment for HCV infection, and/or
HCV viral load is above the limit of quantification (HCV Ribonucleic acid (RNA)positive)
Hepatitis B virus (HBV) infection with the following laboratory evidence: positiveresults of hepatitis B surface (HBs) antigen and presence of Hepatitis B core (HBc)antibody together with HBV-deoxyribonucleic acid (DNA).
Presence of any infection requiring systemic antimicrobial treatment within 7 daysprior to first dose of trial medication. Patients who have any clinical signs ofinfection (e.g. fever or leukocytosis) within 48 hours prior to first dose of trialmedication are not eligible.
Patients with known history of human immunodeficiency virus (HIV) infection who meetone or more of the following criteria:
Cluster of differentiation 4 (CD4+) count <350 cells/μL (local lab assessment)
Viral load >400 copies/mL (local lab assessment)
Not receiving antiretroviral therapy
Receiving established antiretroviral therapy for less than four weeks prior tothe start of study treatment
History of acquired immunodeficiency syndrome (AIDS)-defining opportunisticinfections within 12 months prior to start of study treatment Patients with ahistory of HIV who do not meet any of the criteria above are eligible toparticipate, but the patient must be under the care of a HIV/InfectiousDiseases specialist, or a HIV/Infectious Diseases specialist must be consultedprior to inclusion.
Further exclusion criteria apply
Study Design
Connect with a study center
Shandong Cancer Hospital
Jinan, 250117
ChinaSite Not Available
Shanghai East Hospital
Shanghai, 200120
ChinaSite Not Available
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
JapanActive - Recruiting
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
JapanSite Not Available
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
JapanActive - Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
JapanActive - Recruiting
National Taiwan University Hospital
Taipei, 10048
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
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