Randomized trial assesses GFH375 efficacy in KRAS G12D mutant cholangiocarcinoma and colorectal cancer, suggesting potential for advanced treatments.
Key Points
This research evaluates the efficacy of GFH375, a KRAS G12D inhibitor, in advanced cholangiocarcinoma and colorectal cancer.
Phase I/II study (NCT06500676) evaluating GFH375 safety, tolerability, pharmacokinetics, and efficacy in advanced solid tumors with KRAS G12D mutations.
Tumor assessments every 6 weeks for the first year and every 12 weeks thereafter.
In cholangiocarcinoma, ORR was 35.0% (7/20), DCR 95.0% (19/20), with median PFS at 6.3 months.
In colorectal cancer, ORR was 11.4% (4/35), DCR 77.1% (27/35), with median PFS at 4.1 months.