Phase I Study of BI 765049 Given by Injection in Adults With Advanced or Metastatic Colon, Stomach, or Pancreatic Cancer to Find the Best Dose and Treatment Plan

What this Trial Is About

Researchers are evaluating BI 765049 in adults with advanced cancer of the colon, rectum, stomach, or pancreas that cannot be removed by surgery or has spread. This study includes people whose prior treatments were unsuccessful or who have no other treatment options. The main goal is to find the highest dose of BI 765049 that patients can tolerate, as well as the best dose and administration method for further study. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks and may continue treatment as long as they benefit and can tolerate it. Additional medication is given before and after BI 765049 to help with side effects, and if taken at home, daily phone visits are conducted. The study includes two experimental administration regimens for BI 765049. This is an open-label, non-randomized, phase 1 trial focused on dose escalation. During the study, participants regularly visit the study site, including several overnight hospital stays. Doctors monitor health, perform lab tests, and record any side effects possibly caused by the study drug. The main measure is the occurrence of severe health problems limiting doses during the evaluation period. Secondary measures include treatment response and drug concentration levels. The study may last up to 36 months with ongoing assessments and safety monitoring.

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas