Core Insights - GFH375, a KRAS G12D inhibitor, has entered clinical trials for treating advanced solid tumors, marking a significant step in its development [1][2] - The study, GFH375X1202, received approval from the National Medical Products Administration in September and involves combination therapies with cetuximab or chemotherapy [1] - The primary objective of the trial is to assess the safety, tolerability, efficacy, and pharmacokinetics of GFH375 in patients with solid tumors [1] Group 1 - The first patient has been enrolled in the Ib/II phase study at Peking University Cancer Hospital [1] - The Ib phase will be conducted at approximately 15 centers, focusing on the safety and efficacy of GFH375 in combination with cetuximab or chemotherapy [1] - The II phase will specifically target first-line treatment for advanced pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC) patients [1] Group 2 - Dr. Wang Yu, Chief Medical Officer of the company, expressed optimism about advancing GFH375's clinical development from later lines to first-line treatment for PDAC [2] - Recent data on GFH375's monotherapy for PDAC and non-small cell lung cancer (NSCLC) were presented at ESMO and WCLC, indicating promising efficacy across multiple tumor types [2] - The company anticipates rapid progress in both domestic and international studies based on GFH375, aiming to benefit patients soon [2]
劲方医药-B(02595.HK)：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，适应症涵盖一线胰腺导管腺癌(PDAC)