Mirati Therapeutics announces FDA clears IND application for MRTX849

Mirati Therapeutics announced that the U.S. FDA has cleared the company’s investigational new drug application for MRTX849, a small molecule inhibitor of KRAS G12C. Mirati is developing MRTX849 for the treatment of cancers driven by KRAS G12C mutations. FDA clearance of the IND enables Mirati to initiate its planned Phase 1/2 clinical trial in patients with advanced solid tumors that harbor KRAS G12C mutations. The Phase 1 dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MRTX849 in patients with molecularly-identified KRAS G12C-positive cancers. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Mirati expects the first patient to be enrolled in the trial by January 2019.
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