The collaboration between Verastem Oncology and GenFleet includes three discovery programmes. Credit: Kiattisak Th / Shutterstock.

Verastem Oncology has announced the dosing of the first patient with GFH375/VS-7375, a potent and selective oral KRAS G12D (ON/OFF) inhibitor, as part of a Phase I/II clinical trial in China.

GFH375/VS-7375 is identified as the lead discovery programme from the Verastem Oncology discovery and development partnership with GenFleet Therapeutics.

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The Phase I part of the trial aims to evaluate the safety and efficacy of the therapy in patients with advanced KRAS G12D mutant solid tumours.

This oral inhibitor has shown promise in preclinical studies, demonstrating the potential to address a variety of solid tumours, including those with brain metastases.

The ongoing Phase I trial will involve approximately 20 hospitals across China and establish the recommended Phase II dose.

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Subsequently, Phase II will further investigate GFH375/VS-7375’s efficacy and safety in treating advanced solid tumours such as colorectal cancer, pancreatic ductal adenocarcinoma, and non-small cell lung cancer.

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The collaboration between Verastem Oncology and GenFleet includes three discovery programmes, with the KRAS G12D inhibitor being the foremost.

Verastem Oncology president and CEO Dan Paterson said: “In a short amount of time, we identified GFH375/VS-7375, a novel KRAS G12D (ON/OFF) inhibitor, as our lead discovery program last year and now the first patient has been dosed in the Phase I/II study by GenFleet in China.

“We look forward to leveraging the initial clinical dose escalation data to accelerate our development path in the US, as there are currently no FDA-approved KRAS G12D-targeted treatments despite the high prevalence of this KRAS mutation in various cancers, including pancreatic, colorectal, lung and uterine.”

Verastem Oncology holds exclusive options to license three compounds for development and commercialisation outside of GenFleet’s territories. This is contingent upon the achievement of Phase I milestones.