A study to evaluate different doses of BI 18 31169, either alone or in combination with an anti-PD-1 antibody, in people with various types of advanced cancer (solid tumors).
Principal Investigator
Dott. Fabrizio Carnevale Schianca
Contact Information for Access
Phase
FASE I
Status
ATTIVO
Objective of the study
To determine the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) for BI 1831169, both as monotherapy and in combination with an anti-PD-1 antibody, and to evaluate its efficacy, safety, and tolerability when administered intravenously and intratumorally.
Multiple Cancers:
Melanoma
Pancreas
Colon
Head and Neck
ClinicalTrials.gov ID NCT05155332
Sponsor: Boehringer Ingelheim
Pathologies
Gastrointestinal tumor (GI tumor) , Head and neck cancers , Melanoma , Pancreatic cancer
Medication
BI 1831169 (VSV-GP)
BI 754091 (Ezabenlimab; anti-PD-1 mAb)
Who is eligible to participate in the study?
Patients who are 18 years of age or older and meet the study’s eligibility criteria may participate in this study.
Patients with melanoma who have previously received immunotherapy.
Patients with pancreatic cancer who have previously received chemotherapy.
Patients with oropharyngeal, hypopharyngeal, or laryngeal cancer who have not yet received any treatment or have received only one treatment but whose disease has progressed at least 6 months after the last dose of therapy.
Patients with refractory colon cancer who have already completed all standard treatments, including therapy with checkpoint inhibitors.
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