This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists. The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. During this time, participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within 1 week after the first treatment with the intended dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
BI 765049
Valkyrie Clinical Trials
Los Angeles, California, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: up to 36 months
Objective response (OR)
OR defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST) 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review
Time frame: up to 36 months
Occurrence of DLTs and adverse events during the entire treatment period
Time frame: up to 36 months
Maximum measured concentration (Cmax) of BI 765049 after first administration
Time frame: up to 4 days
Maximum measured concentration (Cmax) of BI 765049 after multiple administrations
Time frame: up to 20 days
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration
Time frame: up to 4 days
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations
Time frame: up to 20 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.