On January 15, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it has dosed the first patient in a Phase 1/2 clinical trial of MRTX849, an investigational KRAS G12C inhibitor for patients with advanced solid tumors that harbor KRAS G12C mutations (Press release, Mirati, JAN 15, 2019, View Source [SID1234532661]).

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"Today we have achieved an important milestone in the battle against cancers driven by KRAS mutations, one of the most common and difficult to treat patient populations. MRTX849 has been designed to specifically target KRAS G12C mutations, which are thought to be responsible for at least 14% of non-small cell lung adenocarcinoma, 4% of colorectal cancer, and subsets of other types of cancers," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "In preclinical studies MRTX849 potently and specifically bound to KRAS G12C and produced durable tumor regressions in patient-derived cancer models implanted in mice. Our Phase 1/2 clinical trial is designed to rapidly advance MRTX849 towards registration and approval."

"There are no approved targeted treatment options for patients with KRAS-driven cancers," said Pasi A. Jänne, M.D., Ph.D., Mirati Scientific Advisory Board Member, and Director of the Lowe Center for Thoracic Oncology at the Dana Farber Cancer Institute. "The development of a direct inhibitor of KRAS G12C is an important advancement in the field and this clinical study is designed to rapidly and efficiently evaluate the tolerability and efficacy of MRTX849 to treat patients with tumors driven by this mutation."

Mirati’s Phase 1/2 clinical trial will evaluate MRTX849 as a single agent 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 advanced solid tumors. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Additional information can be found at View Source

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified KRAS G12C-positive advanced solid tumors