復旦張江(688505.SH):注射用FDA018抗體偶聯劑I期臨牀試驗完成首例受試者入組
格隆匯11月5日丨復旦張江(688505.SH)公佈,公司研發的注射用FDA018抗體偶聯劑(“該藥物”)正在開展I期臨牀研究,於近日成功完成首例受試者入組。
該藥物屬於針對Trop-2靶點的抗腫瘤ADC藥物(antibody-drug conjugate,ADC),臨牀擬開發適應症為晚期實體瘤。Trop-2(人滋養層細胞表面糖蛋白抗原)在人體正常組織中有不同水平的表達,但在乳腺癌、肺癌、胃癌等多種腫瘤中的表達水平都會顯著升高。Trop-2的高度表達在腫瘤生長過程中起到關鍵作用。該藥物將通過與Trop-2結合,遞送抗癌小分子藥物,殺死癌細胞。
該藥物於2021年4月獲得藥物臨牀試驗申請受理通知書,公司I期臨牀研究旨在評價其在晚期實體瘤患者中的安全性、耐受性和藥代動力學特徵,並期待可以初步評估該藥物在晚期實體瘤患者中的療效。該藥物研究於近日已完成首例受試者入組。
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