創勝集團-B(06628.HK):在2022年國際胃癌大會展示TST001單藥在中國I期臨牀試驗初步數據
格隆匯3月10日丨創勝集團-B(06628.HK)發佈公吿,公司已於2022年國際胃癌大會(IGCC)上以海報形式展示了TST001在中國的I期臨牀試驗中的安全性╱耐受性及對胃癌和胰腺癌抗腫瘤活性的初步數據。
該I期研究(NCT04495296)的首要目標是評估在標準治療中或之後進展的晚期或轉移性實體瘤患者中的安全性及耐受性、確定MTD及推薦的2期劑量(RP2D)。次要目標包括評估藥代動力學指標、免疫原性及初步抗腫瘤活性。
“Claudin18.2是具有巨大抗腫瘤潛力的治療癌症的理想靶標。TST001是一種高親和力Claudin18.2人源化抗體,安全性良好,在表達Claudin18.2的胃癌及胰腺癌患者中表現出良好的抗腫瘤活性”,執行副總裁、全球研發負責人兼首席醫學官石明博士表示,“我們將繼續評估單藥對於各類表達Claudin18.2的實體瘤以及與標準治療聯合療法對於一線胃癌的安全性及抗腫瘤活性。我們認為TST001可為胃癌患者提供新的及更有效的治療選擇。”
北京大學腫瘤醫院沈琳教授表示:“胃癌是中國患病率高的惡性腫瘤類型之一。近年來,Claudin18.2成為除HER2及PD-L1之外的前景廣闊的針對胃癌的癌症治療靶標。TST001是全球第二個最先進的靶向Claudin18.2的藥物,呈現良好的抗腫瘤活性,安全性可控。期待其全球胃癌一線治療的3期註冊性臨牀試驗儘快開啟。”
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