Open-label, Multicenter, First-in-human Trial to Explore Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BI 4015092 as Monotherapy and as Combination Therapy in Patients With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Summary

This study is for adults with advanced or metastatic solid tumours, including colorectal cancer and pancreatic ductal adenocarcinoma. People who have a tumour that has a KRAS G12D gene mutation can take part. This study is open for people for whom other treatment may not have worked or may not be suitable. The purpose of this study is to find out how well a new study medicine called BI 4015092 is tolerated and how it affects these tumours when used alone and together with another medicine called cetuximab. This is the first time BI 4015092 is given to humans. This study has 4 parts. In all parts, participants receive BI 4015092, either alone or together with cetuximab. * In Part A1, small groups of participants receive BI 4015092 alone, and the dose is slowly increased to find a suitable dose that people can tolerate. * In Part A2, participants receive BI 4015092 alone at a selected dose to further check how well people tolerate it and to look for early signs that it can stop tumours from growing or make them shrink. * In Part B1, participants receive BI 4015092 together with cetuximab, and the dose of BI 4015092 is slowly increased to find a suitable dose for the combination. * In Part B2, participants receive BI 4015092 together with cetuximab. In this part, participants are put into groups by chance, like drawing names from a hat, and each group gets a different dose of BI 4015092 with cetuximab. Participants can stay in the study as long as they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, study doctors check participants' health and collect information about any health problems. They also regularly check the size of the tumours and whether the cancer has spread to other parts of the body.