君實生物(01877.HK)：重組人源化抗BTLA單克隆抗體注射液中國開展的I期臨牀研究NCT04278859已完成首例患者給藥
格隆匯4月28日丨君實生物(01877.HK)宣佈，重組人源化抗BTLA單克隆抗體注射液(項目代號"TAB004/JS004")在中國開展的I期臨牀研究NCT04278859已完成首例患者給藥。該研究在劑量遞增和病例拓展階段納入所有標準治療失敗且無有效治療方法的晚期實體瘤患者中考察JS004的安全性、耐受性和劑量限制性毒性(DLT)，確定最大耐受劑量(MTD)和II期推薦劑量(RP2D)；適應症拓展階段納入至少一線標準治療失敗後的患者。
TAB004/JS004是全球首個獲得臨牀試驗批准的抗腫瘤BTLA單抗，也是公司繼特瑞普利單抗後，第二個通過美國食品藥品監督管理局的IND審批的自主研發、具有完全自主智慧財產權的在研產品。相關研究表明，TAB004/JS004可以促進腫瘤特異性T淋巴細胞增殖並提高淋巴細胞功能，在BTLA人源化小鼠的腫瘤模型裏減輕腫瘤負荷並提高存活率，且有望與特瑞普利單抗聯合使用，進一步增強腫瘤特異性T細胞的增殖和抗腫瘤細胞因數的產生，為廣大患者提供更多聯合治療方法的選擇。目前，國內外暫無相同靶點產品上市。
2019年4月，TAB004/JS004申請用於晚期不可切除或轉移性實體瘤患者(包含淋巴瘤)以及PD-1抗體耐藥患者的藥物臨牀試驗獲得美國食品藥品監督管理局批准。2019年10月，公司在美國開展的I期臨牀研究(NCT04137900)完成首例患者給藥。2020年1月，TAB004/JS004獲得國家藥品監督管理局簽發的臨牀試驗通知書。
NCT04278859研究是一項在中國開展的I期臨牀研究，在劑量遞增和病例拓展階段納入所有標準治療失敗且無有效治療方法，適應症拓展階段納入至少一線標準治療失敗後的晚期實體瘤患者中考察JS004的安全性、耐受性和劑量限制性毒性(DLT)，確定最大耐受劑量(MTD)和II期推薦劑量(RP2D)。該研究的目標入組人數為200人，主要終點指標為MTD、RP2D以及不良事件╱嚴重不良事件的發生率以及嚴重程度，次要終點指標包括客觀緩解率(ORR)、緩解持續時間(DOR)以及疾病控制率(DCR)等。
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