Phase IbII Study of GFH375 Combined With Cetuximab or Chemotherapy in Adults With Advanced Solid Tumors Having KRAS G12D Mutation

What this Trial Is About

Researchers are studying the safety, effectiveness, and how the body processes two combination treatments involving GFH375 for people with advanced solid tumors that have the KRAS G12D mutation. This Phase IbII study explores Regimen A, which combines GFH375 with Cetuximab, and Regimen B, which combines GFH375 with chemotherapy AG. The study aims to understand both the safety and potential benefits of these therapies and to explore links between biomarkers and clinical outcomes. Participants in Arm A receive GFH375 every day along with Cetuximab given through an intravenous infusion every two weeks. Arm B participants receive GFH375 daily combined with chemotherapy drugs paclitaxel albumin-bound and gemcitabine administered intravenously on Days 1, 8, and 15 of each 4-week cycle. Arm A enrolls people with various advanced solid tumors with the KRAS G12D mutation, while Arm B focuses on those with pancreatic ductal adenocarcinoma PDAC featuring the same mutation. During the study, participants are monitored for side effects, dose-limiting toxicities, and treatment responses using imaging criteria RECIST 1.1. Blood tests will measure GFH375 levels, and safety is assessed from the first dose until 30 days after the last dose, with follow-up lasting up to 24 months. Outcomes like tumor response rate, disease control, progression-free survival, and overall survival are evaluated. This research helps understand how well the treatments work and their safety in people with these cancers.

A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation