研究单位:[1]BeiGene[2]Mission Cancer + Blood,Newton,Iowa,United States,50208[3]Maryland Oncology & Hematology,Columbia,Maryland,United States,21044[4]University of Texas, MD Anderson Cancer Center,Houston,Texas,United States,77030[5]Beijing Cancer Hospital,Beijing,Beijing,China,100142[6]Beijing Friendship Hospital, Capital Medical University,Beijing,Beijing,China[7]Fujian Cancer Hospital,Fuzhou,Fujian,China,350014[8]Guangdong Provincial Hospital of Chinese Medicine,Guangzhou,Guangdong,China[9]Sun Yat-sen University Cancer Center,Guangdong,Guangzhou,China[10]Cancer Hospital of Guizhou Medical University,Guiyang,Guizhou,China,550000[11]Hainan General Hospital,Hainan,Hainan,China[12]Henan Cancer Hospital,Zhengzhou,Henan,China,450000[13]The first affiliated hospital of Zhengzhou University - Oncology - Oncology,Zhengzhou,Henan,China,450052[14]Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology,Wuhan,Hubei,China[15]The affiliated Hospital of Xuzhou Medical university,Xuzhou,Jiangsu,China,221006[16]Jiangxi Cancer Hospital,Nanchang,Jiangxi,China,330029[17]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China[18]General Hospital of Ningxia Medical University,Yinchuan,Ningxia,China[19]The Affiliated Hospital of Qingdao University,Huangdao,Qingdao,China,266500[20]Shandong Cancer Hospital,Jinan,Shandong,China,250117[21]Shanxi Provincial People's Hospital,Taiyuan,Shanxi,China,140100[22]West China Hospital ,Sichuan University,Chengdu,Sichuan,China,610041[23]Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences,Tianjin,Tianjin,China,300020[24]Tianjin Medical University Cancer Institute & Hospital,Tianjin,Tianjin,China[25]Zhejiang Cancer Hospital,Hangzhou,Zhejiang,China,310022
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.