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復宏漢霖(02696.HK):注射用HLX43(靶向PD-L1抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)在晚期/轉移性實體瘤患者中開展的1期臨牀研究於中國境內完成首例患者給藥
格隆匯 11-24 19:44

格隆匯11月24日丨復宏漢霖(02696.HK)公吿,近日,注射用HLX43(靶向PD-L1抗體-新型DNA拓撲異構酶I抑制劑偶聯藥物)("HLX43")在晚期/轉移性實體瘤患者中開展的1期臨牀研究於中國境內(不包括港澳台地區,下同)完成首例患者給藥。

本研究為一項評估HLX43在晚期/轉移性實體瘤患者中的安全性、耐受性的開放、劑量遞增、首次人體1期臨牀研究。研究將採用"3+3"方法,設計6個劑量水平(0.5mg/kg、1mg/kg、2mg/kg、4mg/kg、6mg/kg、8mg/kg),患者將接受不同水平的HLX43靜脈輸注給藥,每三週一次。劑量限制性毒性(DLT)觀察期為HLX43首次給藥後的三週。本研究的主要終點為DLT觀察期內每個劑量組發生DLT事件的患者比例,以及HLX43的最大耐受劑量(MTD)。次要終點包含安全性、藥代動力學參數、免疫原性、初步療效、藥效學指標,以及潛在預測性和耐藥性生物標誌物。

HLX43是由公司利用於2022年11月自蘇州宜聯生物醫藥有限公司許可引進的新型DNA拓撲異構酶I抑制劑小分子毒素-肽鏈連接子與公司自主研發的靶向PD-L1的抗體進行偶聯開發的靶向PD-L1的抗體偶聯藥物(ADC),擬用於晚期/轉移性實體瘤患者的治療。HLX43可與人PD-L1抗原靶點特異性結合,在腫瘤中釋放攜帶的小分子毒素,從而發揮腫瘤殺傷作用。非臨牀藥理學研究、藥代動力學研究及安全性評價表明,HLX43能夠抑制腫瘤生長,且具有良好的安全性。2023年10月,HLX43用於治療晚期/轉移性實體瘤的1期臨牀試驗申請獲國家藥品監督管理局批准。

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