Dallas

Researchers are conducting a Phase I/II open-label study to assess the safety, how the body processes it, and early effects of the investigational drug GDC-7035. The study focuses on adults with advanced or metastatic solid tumors that have a specific genetic change called the KRAS G12D mutation. This trial aims to explore GDC-7035 both alone and alongside other cancer treatments to better understand its potential in this group of patients. The study includes two treatment groups: one receiving only GDC-7035 and another receiving GDC-7035 combined with other anti-cancer therapies. Both groups will undergo dose escalation and expansion phases, where doses are carefully increased and then given at defined levels as per the study plan. This approach helps determine the appropriate dosing and evaluates how the drug works when used alone or with other treatments. Participants will be monitored over time for any side effects, including those severe enough to limit dosing, using a standardized grading scale. The study will track how many participants experience adverse events and dose-limiting toxicities over a four-year period. Safety assessments, drug level measurements, and activity evaluations will be conducted throughout the trial to gather comprehensive information on the treatment effects and participant well-being.