The U.S. Food and Drug Administration (FDA) has cleared the way for Mirati Therapeutics to begin clinical trials of MRTX1133, a potential first-in-class oral treatment for patients with the KRASG12D colorectal cancer mutation. 

About 180,000 colorectal cancer patients in the U.S. and Europe are affected by this mutation, and no targeted oncology treatment options currently exist for them, according to a press release from Mirati.

MRTX1133, an inhibitor of KRASG12D, has shown marked tumor response in preclinical colorectal cancer models, according to the company, as well as a low risk for off-target activity and unwanted drug interactions. 

"This particular mutation has been difficult to target, and we are confident in our novel oral formulation strategy, which we believe will enable near-complete target inhibition over the full dosing interval," said James Christensen, Ph.D., and chief scientific officer at Mirati. "We are thrilled to advance MRTX1133 into clinical development and the potential to positively impact people living with KRASG12D-mutated cancers."

The therapy has also shown promise in pancreatic and lung cancer models. 

The Phase 1/2 clinical trial will launch in early 2023 with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other KRASG12D tumor types.

For more information, view Mirati’s press release or visit Mirati.com/science.