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Revolution Medicines Begins Treating Patients in Phase I Trial of KRAS G12D Inhibitor

NEW YORK – Revolution Medicines said on Tuesday that it has begun treating patients in the Phase I/Ib trial of its KRAS G12D inhibitor, RMC-9805, in solid tumors harboring KRAS G12D mutations.

The trial will enroll up to 290 patients with KRAS G12D-mutant advanced solid tumors, including non-small cell lung, colorectal, and pancreatic cancers. Researchers will evaluate the safety and tolerability of RMC-9805 and determine the recommended Phase II dose, along with measuring preliminary efficacy.

Revolution, based in Redwood City, California, now has three RAS inhibitors in clinical studies, including a KRAS G12C inhibitor and a RAS-multi inhibitor, CEO Mark Goldsmith said in a statement. The company also has a SHP2 inhibitor being studied in several combination trials in KRAS-mutant tumors, including with Amgen's Lumakras (sotorasib) and with Genentech/Exelixis' Cotellic (cobimetinib).

"We are now studying in the clinic three highly innovative RAS(ON) Inhibitors derived from our pioneering tri-complex inhibitor platform that we believe have complementary profiles — RMC-6236 for patients with cancers caused by a wide range of RAS mutations, and the mutant-selective compounds RMC-6291 and RMC-9805 for patients with cancers harboring selected mutations," Goldsmith added in the statement.