Phase 1 Study of BAY3498264 With Sotorasib for Advanced Solid Tumors Having KRASG12C Mutation

What this Trial Is About

Researchers are investigating treatments for people with advanced solid cancers that have a specific genetic change called the KRASG12C mutation. This trial focuses on combining two drugs sotorasib, which is already approved and targets cancer cells with this mutation, and BAY3498264, a new drug that aims to block a related protein called SOS1. The studys main goal is to find out how safe BAY3498264 is when given with sotorasib and to determine the highest safe dose for this combination. Participants will first receive BAY3498264 alone for seven days, followed by treatment cycles of BAY3498264 combined with sotorasib every day. These cycles last 21 days each, and treatment continues as long as it is beneficial and safe, or until the cancer progresses or the participant or doctor decides to stop. The study includes three parts dose escalation to find the right dose, backfill cohorts to gather more safety and drug data, and expansion cohorts to explore further effects and safety. During the study, participants will have blood and urine samples taken and undergo imaging scans like CT, PET, MRI, and X-rays. Heart health will be checked using electrocardiograms, and participants overall health will be closely monitored. Researchers will measure side effects, drug levels in the body, and cancer response, with treatment effects evaluated regularly. The study runs until about mid-2027, with ongoing safety and effectiveness assessments throughout.

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation