GPC3靶点
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突破性进展!乐普生物针对肝细胞癌的II期临床完成首例患者入组
Zhi Tong Cai Jing· 2025-10-16 02:19
Core Insights - Lepu Biotech's MRG006A, a targeted GPC3 antibody-drug conjugate (ADC), has successfully completed the first patient enrollment in a Phase II clinical study for advanced hepatocellular carcinoma (HCC), marking it as the first GPC3-targeted ADC to enter Phase II globally [1][2] - MRG006A utilizes Lepu Biotech's Hi-TOPi ADC technology platform, which allows for precise targeting of GPC3-positive tumor cells, releasing toxins specifically within tumors to achieve targeted cell destruction [1] Group 1: Clinical Development - MRG006A is positioned as a significant innovation in the treatment of HCC, a prevalent malignancy where most patients are diagnosed at advanced stages, and treatment options are limited after first-line therapy failure [1] - The GPC3 antigen, which is expressed in 70%-80% of HCC cases but minimally in normal tissues, is considered a "golden" target for precision therapy [1] - Clinical data indicate that adverse reactions primarily involve liver function abnormalities and mild bone marrow suppression, which are manageable, supporting the feasibility of its clinical application [1] Group 2: Clinical Trial Results - In Phase I trials, MRG006A demonstrated promising results, with significant tumor shrinkage observed in GPC3-positive patients, exceeding expectations during dose escalation studies [2] - The advancement of the Phase II study for MRG006A represents a crucial breakthrough in Lepu Biotech's ADC pipeline and has the potential to address unmet clinical needs in HCC treatment [2]