Study

Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time. This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

Why this Research Matters

Part 1 of this study plans to learn more about: To find the recommended dose of the study drug, BI 1831169, that can be used in Part 2 of this study. This will be done by testing different doses of the study drug to see which dose has less unacceptable side effects in subjects with solid tumor cancer. Test the safety, effectiveness, and side effects of the study drug, BI 1831169. Test how the study drug is used by the body and how fast or slow the study drug moves through or out of the body. This is the first time that BI 1831169 will be given to humans. Therefore, it is investigational for this study. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). You are being asked to be in this research study because you have solid tumor cancer that worsened after receiving standard therapy, or for which no effective standard therapy is available, or you are not able to receive standard therapy.

Who can Participate

Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov