Verastem Oncology Receives FDA Clearance for KRAS G12D Inhibitor in Solid Tumours
Thursday, April 24, 2025
Verastem Oncology has received clearance from the United States Food and Drug Administration (FDA) to begin clinical trials for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor.
VS-7375 is designed to inhibit both active and inactive forms of the KRAS G12D mutation, which is the most common KRAS mutation in human cancers. This mutation appears frequently in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers.
Currently, there are no FDA-approved treatments that specifically target this mutation.
VS-7375 is the lead candidate emerging from Verastem Oncology’s collaboration with GenFleet Therapeutics.
The Phase 1/2a study is scheduled to begin in mid-2025 and will target patients with advanced solid tumours, including pancreatic, colorectal, and non-small cell lung cancers.
The investigational treatment, also known as GFH375 in China, has already completed early-stage clinical evaluation by GenFleet Therapeutics. Preliminary results from the Chinese study reported oral bioavailability, an absence of dose-limiting toxicities across six dose levels, and partial responses in several patients with pancreatic and lung cancers.
The upcoming US-based trial will use data from the GenFleet study to determine the starting dose and will include plans for dose escalation.
The trial will assess the safety and effectiveness of VS-7375 as a standalone treatment and in combination with other therapies.
Source: verastem.com
