The COVALENT-102 trial will investigate BMF-219 in patients with non-small cell lung cancer, colorectal and pancreatic cancers.
The first patient has been dosed in the phase 1/2b COVALENT-102 trial, examining BMF-219 in adults with KRAS-mutated unresectable, locally advanced or metastatic non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma, according to Biomea Fusion Inc, the manufacturer of the oral drug.
Pre-clinical studies (meaning those that were not done in humans) suggested the BMF-219 broadly inhibits the KRAS mutation, which could play a role in the growth and spread of cancer cells.
“We are eager to explore the potential of BMF-219 as a pan-KRAS inhibitor in patients with three of the most prominent KRAS-mutant solid tumor types, including those with tumors that have failed to respond to investigational and approved mutation-specific KRAS inhibitors,” said Dr. Steve Morris, Biomea’s chief medical officer in a press release.
The initial goal of the COVALENT-102 trial is to determine the proper dosing of the drug. Then, that dose will be used in a larger patient population, where safety and tolerability will be studied. BMF-219 will be administered either once daily or twice daily in 28-day cycles.
To be eligible for the trial, patients must have progression and measurable disease after at least one prior line of systemic therapy (or two to four prior therapies for those with lung cancer); have a life expectancy of three months or longer; have little to no restrictions in the activities of daily living (ECOG score of 0-2); have adequate blood, liver and kidney function; and must use birth control measures if within childbearing age.
Currently patients are being recruited for the study in cancer centers Arizona, Illinois and Virginia. The researchers plan on adding trial sites and recruiting patients in California, Missouri, New York, Ohio, Texas and Washington as well.
“As a covalent menin inhibitor, we believe BMF-219 has critical advantages over late stage, mutation-specific inhibitors of KRAS including independence on the KRAS activation state, reduced likelihood for acquisition of resistance mutations, and its potential to address multiple activating KRAS mutations,” Morris said.
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