This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part. The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time. Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Solution for infusion/injection
Yale Cancer Center
New Haven, Connecticut, United States
NEXT Oncology-San Antonio-65273
San Antonio, Texas, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hospital Quiron. I.C.U.
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Karolinska Universitetssjukhuset Stockholm
Stockholm, Sweden
Occurrence of DLTs in the MTD Evaluation Period
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period is reported as count of participants with DLTs in the MTD evaluation period.
Time frame: First treatment cycle, i.e., 21 days.
Occurrence of DLTs During the On-treatment Period
Occurrence of DLTs during the on-treatment period is reported as count of participants with DLTs during the on-treatment period.
Time frame: From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
Occurrence of AEs During the On-treatment Period
Occurrence of adverse events (AEs) during the on-treatment period is reported as count of participants with AEs during the on-treatment period.
Time frame: From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days.
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