Verastem Oncology Announces First Patient Dosed with GFH375/VS-7375, a KRAS G12D (ON/OFF) Inhibitor, in a Phase 1/2 Trial in China as Part of Collaboration with GenFleet Therapeutics
GenFleet’s IND in China was cleared in June 2024; this is the first discovery program from the collaboration Verastem announced in 2023 to advance into human clinical trials
Verastem plans to initiate development studies outside of China after evaluating initial dose escalation data from the Phase 1 study in China
Excerpt from the Press Release:
BOSTON–(BUSINESS WIRE)–Jul. 12, 2024– Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the first patient has been dosed in a Phase 1/2 trial in China, conducted by GenFleet Therapeutics, evaluating GFH375/VS-7375, a KRAS G12D (ON/OFF) inhibitor.
GFH375/VS-7375, was selected as Verastem’s lead discovery program from its collaboration with GenFleet established in 2023. GFH375/VS-7375 is an oral, potent and selective KRAS G12D dual inhibitor of ON (GTP) and OFF (GDP) states. Preclinical data presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2024 demonstrated oral bioavailability across preclinical species, strong anti-tumor activity as a single agent and potency against intracranial tumor models suggesting the potential to treat brain metastases.
“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 1/2 study by GenFleet in China,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “We look forward to leveraging the initial clinical dose escalation data to accelerate our development path in the U.S., 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.”
The Phase 1 study is being conducted in approximately 20 hospitals currently in China and will evaluate the safety and efficacy of GFH375/VS-7375 in patients with advanced KRAS G12D mutant solid tumors.
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