Study to Evaluate Safety and Effectiveness of BAY 3771249 Alone or With Cetuximab in Adults With Advanced or Metastatic Colorectal Cancer Having KRAS G12D Mutation

What this Trial Is About

Researchers are exploring new treatments for people with advanced or metastatic colorectal cancer CRC who have a specific mutation called KRAS G12D. This mutation is linked to fewer treatment options and a poorer outlook. The study is assessing the safety, how well people tolerate the study drug BAY 3771249, how the body processes it, and whether it can help shrink or control tumors in this group. The study includes people who have already tried other treatments for their cancer. Participants will receive BAY 3771249 either alone or combined with another drug called cetuximab. The study begins with a dosage escalation phase where the dose of BAY 3771249 is gradually increased to find the highest safe amount. After this, more participants may join the dosage expansion phase, receiving the study drugs until their disease progresses or unacceptable side effects occur. The treatments are given orally for BAY 3771249 and by intravenous infusion for cetuximab. During the study, participants will have regular health assessments, including monitoring for side effects and laboratory tests for vital signs and blood work. Researchers will track tumor response using standard criteria and measure drug levels in the blood over time. Participants may continue receiving BAY 3771249 after the study if they benefit. The total participation time varies, with safety and effectiveness monitored for up to about two years.

A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation