Verastem Doses First Patient in U.S. Trial for Oral KRAS G12D Inhibitor VS-7375

Verastem Oncology’s oral KRAS G12D (ON/OFF) Inhibitor in the First Patient

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Announcement

Verastem Oncology, a biopharmaceutical company known for introducing new medicines for patients suffering from cancer-related RAS/MAPK, has announced that the first patient has been dosed in VS-7375-101. The phase 1/2a clinical trial evaluated the potential of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor in US patients suffering from advanced KRAS G12D mutant solid tumors. The successful results of the dose in the first patient will give the ticket to explore and expand the treatment in various conditions. Later, this new medicine will contribute to the healthcare market globally.

Clinical Trial (study)

Phase 1/2a of a VS-7375 study was held in the US for global acceptance and expansion. The trial will assess the efficacy and safety of VS-7375 in patients having advanced KRAS G12D mutant solid tumors. The plan is to introduce monotherapy, beginning with the dose escalation starting at 400 mg. It will be based on an efficient dose, which was identified in the phase1/2 clinical study held in China by the company’s partner. Company’s partner GenFleet Therapeutics reported primary efficacy and safety results from its phase 1 dose-escalation, a study of VS-7375, also known as GFH375in China, at the ASCO Annual meeting 2025. Verastem is up to an escalated dose at all dose levels. The primary aspect of efficacy and safety was visible in advanced KRAS G12D mutant solid tumor cancer patients in Genfleet’s study.

After the successful completion of the dose-escalation period, the company will move ahead with the recommendation and evaluation of the phase 2 dose a monotherapy VS-7375. A therapy is planned for expansion in various patients with non-small cell lung cancer and advanced pancreatic cancer. Besides monotherapy dose escalation, Verastem will also assess VS-7375 by merging with cetuximab in advanced solid tumors. According to the result of the phase 1 dose escalation with the merger of cetuximab and VS-7375, Verastem will plan to introduce this combination in colorectal cancer.

Views and Statements

President and Chief Executive Officer of Verastem Oncology, Dan Paterson, said, “The company continues to accelerate double the progress than planned at the beginning of the year, including the commercial launch and FDA approval, as well as the trial expansion and positive results in metastatic pancreatic cancer. The company is now thrilled to achieve a milestone with the first clinical trial and patient dose with VS-7375."

MD, Chief Medical Officer of Verastem Oncology, John Hayslip said, “We are happy that the first patient has agreed to the treatment with VS-7375 in the US. The company believes that it can accelerate VS-7375 dual inhibition of ON/OFF states for better efficacy with KRAS G12D selective agents.”