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康辰藥業(603590.SH):KC1036治療晚期實體瘤患者的I期臨牀研究符合預期研究效果
格隆匯 09-08 15:46

格隆匯9月8日丨康辰藥業(603590.SH)公佈,KC1036是公司自主研發的境內外均未上市的化學藥品1類創新藥,2020年1月22日,公司在指定信息披露媒體披露了KC1036《關於獲得臨牀試驗通知書的公吿》。目前,公司正在開展的KC1036治療晚期實體瘤患者的I期臨牀研究(NCT04387916)符合預期研究效果,公司正在按計劃積極推進該項目的研究。為使廣大投資者進一步瞭解上述研究臨牀試驗數據的情況,現將相關數據公吿如下:

(1)方法及目的

NCT04387916研究是一項評價KC1036治療晚期復發或轉移性實體瘤的安全性、耐受性和藥代動力學的開放、劑量遞增的I期臨牀研究(方案編號:KC1036-I-01)。該研究採用開放、單臂試驗設計,由三個階段組成:劑量遞增階段、劑量擴展階段和II期試驗推薦劑量(RP2D)擴展階段。

試驗目的在於評價KC1036在晚期復發或轉移性實體瘤患者中的安全性和耐受性,確定最大耐受劑量(MTD)和II期試驗推薦劑量(RP2D),以及評價KC1036在晚期復發或轉移性實體瘤患者中的藥代動力學(PK)特徵和評價KC1036治療晚期復發或轉移性實體瘤患者的客觀緩解率(ORR),持續緩解時間(DOR),疾病控制率(DCR)和無進展生存期(PFS)(根據RECIST1.1標準)。

該研究第一階段採用傳統的3+3劑量遞增(起始劑量為加速滴定),設計5個劑量組10mg、20mg、40mg、60mg和80mg,受試人羣為晚期復發或轉移性實體瘤患者。

(2)試驗結果

該研究從2020年9月4日開始入組第一例受試者,在已入組23例受試者中,肺腺癌4例,直腸癌4例,膽管癌3例,胸腺癌3例,肺鱗癌2例,食管癌2例,軟組織肉瘤2例,其他腫瘤3例。ECOG評分為0-1分。受試者既往系統治療中位線數為2線。

截至該次數據分析日,在劑量遞增階段,已完成80mg劑量組第三例病人的劑量限制性毒性(DLT)觀察,尚未觀察到劑量限制性毒性(DLT)反應;在13例受試者/5個劑量水平中,未觀察到劑量限制性毒性(DLT)事件,該試驗已順利進入第二階段劑量拓展研究。

關於療效評估,有15例受試者至少完成了1次腫瘤評估,其中2例(1例肺腺癌和1例食管癌的受試者)最佳療效為部分緩解(PR),10例受試者的最佳療效為疾病穩定(SD),3例受試者因疾病進展(PD)而出組;客觀緩解率(ORR)為13.3%,疾病控制率(DCR)為80%;2例部分緩解(PR)受試者目前仍處於持續緩解狀態,持續緩解時間已達到3個月。

關於安全性,觀察到的較常見不良反應為臨牀實驗室檢測指標異常、噁心等,絕大多數為輕中度不良反應(1~2級)。藥代動力學特徵顯示KC1036的血藥濃度隨劑量遞增而表現出升高趨勢。

該研究結果顯示,KC1036單藥具有良好的安全性及耐受性,在上述晚期實體瘤患者中顯示了較突出的抗腫瘤活性。

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