創勝集團-B(06628.HK)與百時美施貴寶合作開展TST001聯合歐狄沃®用於局部晚期或轉移性胃癌╱胃食管連接部癌患者全球臨牀試驗
格隆匯3月22日丨創勝集團-B(06628.HK)發佈公吿,公司已與百時美施貴寶建立全球臨牀合作開展TST001(公司開發的一種靶向Claudin18.2的在研人源化單克隆抗體)聯合歐狄沃® (納武利尤單抗)(百時美施貴寶的抗PD-1療法)用於治療不可切除局部晚期或轉移性胃癌或胃食管連接部癌(GC/GEJ)患者的全球臨牀試驗。
根據披露,本次合作包括兩項開放、多中心、全球I/II期研究,一項在美國進行,一項在中國進行,以評估TST001聯合歐狄沃用於既往曾接受或未接受治療的不可切除局部晚期或轉移性Claudin18.2表達的胃癌╱胃食管連接部癌患者的安全性、耐受性及抗腫瘤療效。根據協議的條款,集團將為試驗的申辦者,而百時美施貴寶將向集團提供歐狄沃用於與TST001的聯合療法研究。
TST001是一種靶向Claudin18.2的高親和力人源化單克隆抗體。在目前進行的臨牀試驗中,無論作為單藥治療還是與化藥聯合,TST001都顯示出良好的安全性,並在表達Claudin18.2的胃癌及其他實體瘤的患者中顯示出令人鼓舞的抗腫瘤活性信號。TST001通過NK細胞介導的抗體依賴性細胞毒性來發揮其抗腫瘤活性,在臨牀前模型中,加入PD-1抑制劑及化療產生了協同效應。集團的執行副總裁、全球研發負責人兼首席醫學官石明博士表示:“集團對TST001聯合歐狄沃治療轉移性胃癌╱胃食管連接部癌的試驗充滿期待,其有望成為胃癌患者的新治療選擇”。
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