復宏漢霖(02696.HK):HLX07(重組抗EGFR人源化單克隆抗體注射液)聯合化療用於晚期實體瘤治療的1b/2期臨牀研究結果顯示其安全性及耐受性良好
格隆匯2月2日丨復宏漢霖(02696.HK)公吿,近日,公司自主研發的HLX07(重組抗EGFR人源化單克隆抗體注射液)("HLX07")聯合化療已於中國境內(除港澳台地區,下同)完成1b/2期臨牀研究,其在一項於晚期實體瘤患者中開展的1b/2期臨牀研究中展現了良好的安全性及耐受性。
本研究為一項開放標籤、劑量遞增的1b/2期臨牀研究,旨在探索HLX07與不同化療方案聯合時在晚期實體瘤患者中的安全性和最大耐受劑量("MTD")。研究採用貝葉斯最優區間設計(BOIN),合格的受試者將接受靜脈輸注不同劑量的HLX07(400、600或800mg每週一次)分別聯合3種固定劑量化療方案的治療,化療方案包括:(1)吉西他濱及順鉑;(2)紫杉醇及卡鉑;及(3)mFOLFOX6方案。
本研究的主要終點為HLX07與不同化療方案聯合的劑量限制毒性("DLT")發生率及MTD。次要終點包括不良事件的發生率與類型以及初步療效。試驗結果顯示,HLX07的安全性和耐受性良好。研究過程中未發生與HLX07相關的DLT事件,HLX07與不同化療方案聯合的MTD未達到。
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