君實生物(688180.SH)：NCT04601285研究已完成首例患者給藥
格隆匯11月25日丨君實生物(688180.SH)公佈，近日，公司產品注射用重組人源化抗Trop2單抗-Tub196偶聯劑(項目代號：JS108)的I期臨牀研究(NCT04601285研究)已完成首例患者給藥。
JS108為注射用重組人源化抗Trop2單抗-Tub196偶聯劑。Trop2是重要的腫瘤發展因子，其高表達於多種腫瘤，如乳腺癌、胃癌、非小細胞肺癌、小細胞肺癌、結腸癌、胰腺癌等，可促進腫瘤細胞增殖、侵襲、轉移擴散等過程，其高表達與腫瘤患者生存期縮短及不良預後密切相關，因此以Trop2為靶點的抗腫瘤藥物研究具有重要意義。2020年7月，JS108臨牀試驗申請獲得國家藥品監督管理局批准。
近年來，分子靶向藥物聯合化療藥物治療惡性腫瘤已經成為多種腫瘤的成熟治療方案，並且取得了很好的療效，但是比單用化療藥物治療惡性腫瘤增加了副作用和風險。抗體偶聯藥物(Antibody Drug Conjugates，ADCs)是單克隆抗體與抗腫瘤毒性小分子的偶聯產物，通過化學鍵將細胞毒藥物與單克隆抗體偶聯組成ADCs，並利用抗體可特異性識別腫瘤細胞的特性，可“精確”地把毒性小分子運送到腫瘤細胞。因此，在提高腫瘤部位藥物濃度的同時降低了正常組織、器官的藥物濃度，達到了高效低毒的抗腫瘤效果。
NCT04601285研究是一項旨在評估JS108用於治療晚期實體瘤受試者的安全性、耐受性、PK特徵及有效性的開放、首次人體的I期臨牀研究。該研究的主要研究終點為最大耐受劑量(MTD)、劑量限制性毒性(DLT)事件、不良事件(AE)發生率及嚴重程度、異常實驗室指標。次要研究終點為PK特徵、免疫原性、有效性、Trop2蛋白表達水平。研究分為3個階段：劑量遞增階段、劑量拓展階段和臨牀拓展階段，三個階段分別計劃入組約16-36例、12-27例和60-90例晚期實體瘤受試者。
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