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The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.
Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICP-022 | Experimental | Subjects will take ICP-022 150mg once daily (QD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-022 | Drug | ICP-022 at a dose of 150mg PO QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major response rate(MRR) | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of adverse events and serious adverse events | The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria | Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days. |
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Key Inclusion criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) | Hefei | Anhui | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39563886 | Derived | Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024. | |
| 36313145 | Derived | Cao XX, Jin J, Fu CC, Yi SH, Zhao WL, Sun ZM, Yang W, Li DJ, Cui GH, Hu JD, Liu T, Song YP, Xu B, Zhu ZM, Xu W, Zhang MZ, Tian YM, Zhang B, Zhao RB, Zhou DB. Evaluation of orelabrutinib monotherapy in patients with relapsed or refractory Waldenstrom's macroglobulinemia in a single-arm, multicenter, open-label, phase 2 study. EClinicalMedicine. 2022 Oct 4;52:101682. doi: 10.1016/j.eclinm.2022.101682. eCollection 2022 Oct. |
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| Duration of Major Mitigation (DOMR) |
| Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days. |
| Progression Free Survival (PFS) | Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days. |
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| West China hospital of sichuan university | Sichuan | Chengdu | China |
| Union Hospital affiliated to Fujian Medical University | Fuzhou | Fujian | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Henan Provincial Peoples's Hospital | Zhengzhou | Henan | China |
| Tongji Hospital affiliated to Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Ruijin Hospital affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | China |
| Hospital of Hematology, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | China |
| Union Hospital affiliated to Huazhong University of Science and Technology | Hubei | Wuhan | China |
| The First Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang | China |