A first-in-human clinical trial testing RMC-5127, an experimental treatment for people with pancreatic cancer and other cancers marked by a specific genetic mutation called RAS G12V, is now recruiting participants in the U.S.
The Phase 1 trial (NCT07349537) is open to adults with pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer, as well as those with other types of solid tumors. To be eligible, the individuals’ tumors must have a confirmed RAS G12V mutation, and patients must have progressed on or been intolerant to standard treatments for their specific cancer type.
All participants in the trial will receive RMC-5127, either alone or in combination with other cancer therapies, Revolution Medicines, the company developing RMC-5127 and sponsoring the trial, said in a company press release.
The trial’s main goal is to evaluate the safety of the experimental treatment, the developer noted.
Participants are being recruited at four sites: three in Texas and one in Virginia. Revolution announced that the trial’s first participant has already been dosed.
“By bringing RMC-5127 to the clinic, we are building on our well-validated RAS(ON) inhibitor approach and extending it to RAS G12V, the second most common RAS mutation driving human cancers, where there are no approved targeted treatment options,” said Alan Sandler, MD, Revolution’s chief development officer.
The trial is expected to run through 2028.
RMC-5127 aims to block abnormal cell growth
RAS is a protein that helps to control cell growth. The protein can either be in an on state, which triggers growth, or an off state, which doesn’t.
Many cancers are marked by mutations that keep RAS in the on state, driving cancer cell growth. RAS G12V is one such mutation; according to Revolution, about 48,000 people in the U.S. are diagnosed each year with a cancer harboring this exact mutation. In addition to PDAC, this mutation is also common in certain types of colon and lung cancer.
RMC-5127 is an oral treatment that’s designed to specifically shut down the molecular signaling pathway activated by the RAS G12V mutation to drive cancer cell growth. In doing so, the therapy aims to block the driver of abnormal cell growth.
Revolution is developing several other therapies that aim to shut down the activity of RAS proteins carrying various specific mutations that drive cancer cell growth, the company noted.
“As our fifth disclosed mutant-selective RAS(ON) inhibitor and fourth clinical-stage program, RMC-5127 broadens the RAS variant coverage of our growing portfolio and opens a suite of development opportunities aimed at improving outcomes for patients with RAS-driven cancers,” Sandler said.
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