Core Insights - The company has initiated the clinical trial of GFH375, a KRAS G12D inhibitor, for treating advanced solid tumors, marking a significant step in its clinical development [1][2] - The trial, approved by the National Medical Products Administration, aims to evaluate the safety, efficacy, and pharmacokinetics of GFH375 in combination with chemotherapy and cetuximab [1] - GFH375 has shown promising results in preclinical studies and has received fast track designation from the FDA for treating advanced KRAS G12D mutant pancreatic ductal adenocarcinoma (PDAC) [2] Group 1 - GFH375's clinical trial (GFH375X1202) has commenced with the first patient enrolled at Peking University Cancer Hospital [1] - The trial will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with either cetuximab or chemotherapy [1] - The Phase II trial will specifically target first-line treatment for advanced PDAC and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer, expressed optimism about advancing GFH375 into frontline PDAC treatment, highlighting its potential across multiple tumor types [2] - The single-agent study of GFH375 is set to begin in June 2024, with promising data already presented at major oncology conferences [2] - GFH375 is a highly selective oral small molecule that inhibits KRAS G12D, effectively disrupting downstream signaling pathways and tumor cell proliferation [2] Group 3 - The company has entered into a licensing and early collaboration agreement with Verastem for three RAS/MAPK-driven cancer products [3] - Verastem has chosen GFH375/VS-7375 as the lead project, granting them exclusive rights outside Greater China upon achieving specific clinical milestones [3] - The licensing agreement allows Verastem to develop and commercialize GFH375 outside of China, while the company retains rights within the country [3]
劲方医药-B：KRAS G12D抑制剂GFH375联合西妥昔单抗或化疗治疗晚期实体瘤的Ib/II期研究完成首例患者给药