和鉑醫藥-B(02142.HK):新一代抗CTLA-4抗體在澳大利亞開展的Ib/IIa期臨牀試驗完成首例患者給藥
格隆匯5月11日丨和鉑醫藥-B(02142.HK)宣佈,其HBM4003針對澳大利亞患有晚期黑色素瘤、肝癌(HCC)、腎癌(RCC)及其他瘤種患者的I期第2部分("Ib/IIa期")臨牀研究(研究編號4003.1)已完成首例患者給藥。此研究將評估HBM4003作為單藥治療多種實體瘤的安全性、耐受性、藥代動力學╱藥效動力學(PK/PD)及抗腫瘤療效。臨牀I期第1部分研究結果已向歐洲腫瘤醫學學會(ESMO)遞交。
作為公司的新一代抗CTLA-4抗體,HBM4003目前正在全球開展針對晚期實體瘤患者的開放性、多中心臨牀試驗。I期第1部分研究側重劑量爬坡試驗,而Ib/IIa期研究將繼續擴展劑量,以進一步探索HBM4003針對多個晚期實體瘤種的抗腫瘤療效。
據悉,HBM4003是抗CTLA-4全人源單克隆重鏈抗體,產生自和鉑醫藥HarbourMice®。HBM4003顯示出增強的ADCC(抗體依賴的細胞毒性作用),對腫瘤微環境中高表達CTLA-4的Treg細胞具有極高的特異性。其強效的抗腫瘤作用、差異化的藥代動力學特徵和持久的藥效展現出良好的產品特性,這種新穎和差異化的作用機制使其具有提高治療效果並顯著降低藥物毒性的潛力。
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