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GenFleet to Begin Phase III Trial of GFH925 in KRAS G12C-Mutant Colorectal Cancer

NEW YORK – GenFleet Therapeutics on Friday said it has been cleared by the US Food and Drug Administration to begin a Phase III trial of its KRAS G12C inhibitor, GFH925, in KRAS G12C-mutant refractory metastatic colorectal cancer.

The trial will include colorectal cancer patients who have received at least two prior lines of therapy or are intolerant to their last treatment. Researchers will evaluate GFH925 versus the current standard-of-care treatment for colorectal cancer. Further details about the study have not been released.

GenFleet, based in Shanghai, is also evaluating GFH925 with Eli Lilly's EGFR inhibitor Erbitux (cetuximab) as a front-line combination treatment in patients with KRAS G12C-mutant non-small cell lung cancer in a Phase Ib/II trial. The firm is also studying the drug as a monotherapy for KRAS G12C-mutant NSCLC and gastrointestinal tumors.

Last year, GenFleet out-licensed rights to commercialize GFH925 and two other RAS-targeting programs outside of China to Verastem Oncology.