GenFleet Therapeutics has received approval from the Chinese National Medical Products Administration (NMPA) for a clinical trial application to commence the Phase I/II trial of GFH375 (VS-7375) to treat patients with advanced solid tumours carrying the KRAS G12D mutation.

The multicentre, open-label trial will be carried out at nearly 40 hospitals including the Shanghai Chest Hospital in the country.

The Phase I segment of the study will focus on assessing the safety, tolerability, and initial efficacy of GFH375 in patients with advanced G12D-mutant solid tumours. It will also establish the recommended Phase II dose (RP2D).

The subsequent Phase II portion will further evaluate the therapy’s efficacy in treating advanced solid tumours.

Patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer and colorectal cancer with a high G12D mutation prevalence will be enrolled in the trial.

The study will also assess the mechanisms behind patient responses and resistance to the treatment.

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An oral KRAS G12D inhibitor, GFH375 acts on the ‘ON’ and ‘OFF’ states of the KRAS G12D protein.

According to preclinical data, GFH375 showed preliminary safety, favourable oral bioavailability and potent efficacy, including potential treatment for brain metastases in G12D-mutant cancers.

Last year, GenFleet signed a discovery and development partnership with Verastem Oncology to progress the development of three oncology programmes, with GFH375 being the first.

GenFleet chief medical official Yu Wang said: “We are delighted to enter a clinical trial to assess the clinical benefits of our G12D targeted programme in a monotherapy setting and explore the possibilities of synergistic effects that may arise from potential combination regimen in future.

“GenFleet’s expertise in developing RAS-targeted therapies has been exemplified by the successful development of fulzerasib (GFH925, a KRAS G12C inhibitor) and the NDA acceptance of its monotherapy for NSCLC in China.

“This allows GenFleet to be well positioned to advance our second RAS pathway inhibitor GFH375 into the clinical trial, as well as other RAS-inhibiting therapies in our pipeline.”

In April, the US Food and Drug Administration granted approval for GenFleet to commence a Phase III trial of GFH925 for the treatment of refractory metastatic colorectal cancer.