Verastem Oncology has received clearance from the United States Food and Drug Administration (FDA) to begin clinical trials for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor.

Verastem Oncology已获得美国食品药品监督管理局（FDA）的批准，开始进行口服KRAS G12D（ON/OFF）抑制剂VS-7375的临床试验。

VS-7375 is designed to inhibit both active and inactive forms of the KRAS G12D mutation, which is the most common KRAS mutation in human cancers. This mutation appears frequently in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers.

VS-7375旨在抑制KRAS G12D突变的活性和非活性形式，这是人类癌症中最常见的KRAS突变。该突变常见于胰腺癌（37%）、结直肠癌（12.5%）、子宫内膜癌（8%）和非小细胞肺癌（5%）。

Currently, there are no FDA-approved treatments that specifically target this mutation.

目前，尚无专门针对这种突变的FDA批准的治疗方法。

VS-7375 is the lead candidate emerging from Verastem Oncology’s collaboration with GenFleet Therapeutics.

VS-7375是Verastem Oncology与GenFleet Therapeutics合作中产生的主要候选药物。

The Phase 1/2a study is scheduled to begin in mid-2025 and will target patients with advanced solid tumours, including pancreatic, colorectal, and non-small cell lung cancers.

1/2a期研究计划于2025年年中开始，目标患者为晚期实体瘤患者，包括胰腺癌、结直肠癌和非小细胞肺癌。

The investigational treatment, also known as GFH375 in China, has already completed early-stage clinical evaluation by GenFleet Therapeutics. Preliminary results from the Chinese study reported oral bioavailability, an absence of dose-limiting toxicities across six dose levels, and partial responses in several patients with pancreatic and lung cancers..

该研究性治疗药物在中国也被称为GFH375，已经由GenFleet Therapeutics完成了早期临床评估。来自中国研究的初步结果显示，口服生物利用度良好，在六个剂量水平上均未出现剂量限制性毒性，并且在数名胰腺癌和肺癌患者中观察到部分缓解。

The upcoming US-based trial will use data from the GenFleet study to determine the starting dose and will include plans for dose escalation.

即将进行的美国试验将使用GenFleet研究的数据来确定起始剂量，并包括剂量递增计划。

The trial will assess the safety and effectiveness of VS-7375 as a standalone treatment and in combination with other therapies.

该试验将评估VS-7375作为单一疗法及与其他疗法联合使用的安全性和有效性。

Source: verastem.com

来源：verastem.com