By Fineline Cube 
Shanghai-based biotech GenFleet Therapeutics announced that its GFH375/VS-7375, an oral KRAS G12D inhibitor co-developed with Verastem Oncology (NASDAQ: VSTM), has received clinical trial approval from the US Food and Drug Administration (FDA). The Phase I/IIa trial evaluating the compound in KRAS G12D-mutant advanced solid tumors is scheduled to commence in mid-2025 across the US.
Partnership and Development
In August 2023, GenFleet entered into a USD 380 million partnership with Verastem, granting exclusive option rights for three pipeline assets. Verastem exercised its option on GFH375/VS-7375 in January 2025. The Phase I study will initiate with a starting dose based on efficacious data from GenFleet’s initial study to accelerate trial progression.
Clinical Trial Design
The Phase I/IIa trial will assess the efficacy and safety of VS-7375 both as a monotherapy and in combination with other therapies. Verastem plans to escalate dosing to levels where cancer responses were observed in GenFleet’s study. The trial will focus on patients with advanced solid tumors, including pancreatic, colorectal, and non-small cell lung cancers.-Fineline Info & Tech