You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
開拓藥業-B(09939.HK):K-1單抗聯合NIVOLUMAB治療晚期肝細胞癌的II期臨牀試驗完成美國首例患者給藥
格隆匯 05-04 18:19

格隆匯5月4日丨開拓藥業-B(09939.HK)宣佈,於2022年5月2日,公司ALK-1單抗(GT90001)聯合Nivolumab治療晚期肝細胞癌("HCC")的全球多中心II期臨牀試驗(NCT05178043)已完成美國首例患者給藥("II期臨牀試驗")。

該II期臨牀試驗是一項開放標籤、多中心研究,旨在評估GT90001聯合Nivolumab用於治療在接受如Atezolizumab或Bevacizumab免疫檢查點抑制劑(ICI)(聯合或者不聯合酪氨酸激酶抑制劑(TKI))一線治療後不耐受或惡化的晚期HCC患者的療效及安全性。該II期臨牀試驗計劃入組總共105名受試者。擬用劑量為7毫克╱公斤GT90001聯合240毫克Nivolumab,每兩週注射一次。主要臨牀終點為獨立審查委員會根據實體瘤療效評價標準(RECIST)v1.1評估的客觀緩解率(ORR)。

此前,在中國台灣進行的GT90001及Nivolumab聯合治療晚期HCC患者的II期臨牀試驗的初步數據已yu 2021年1月舉行的美國臨牀腫瘤學會胃腸道腫瘤研討會上發佈。初步數據顯示聯合療法的療效令人鼓舞且安全性良好,客觀緩解率(ORR)達到40%。於2021年10月9日,GT90001及Nivolumab聯合治療晚期HCC的臨牀試驗獲中國國家藥品監督管理局同意開展。 

Follow us
Find us on Facebook, Twitter , Instagram, and YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
uSMART
Wealth Growth Made Easy
Open Account