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Clinical Trials associated with RocbrutinibA Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL
This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma [Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)].
一项评估LP-168联合R-CHOP方案治疗初治B细胞淋巴瘤有效性和安全性的Ib期研究
[Translation] A Phase Ib study evaluating the efficacy and safety of LP-168 combined with R-CHOP in the treatment of previously untreated B-cell lymphoma
主要目的: 评估LP-168联合R-CHOP(利妥昔单抗、环磷酰胺、长春新碱、多柔比星、泼尼松)方案在B细胞淋巴瘤患者的安全性、耐受性、剂量限制性毒性(DLT)、药代动力学(PK)特征,确定联合方案的最大耐受剂量(MTD)和III期推荐剂量(RP3D)。次要目的: 评估LP-168联合R-CHOP方案治疗B细胞淋巴瘤患者的初步疗效,包括但不限于总体缓解率(ORR)、完全缓解率(CRR)、缓解持续时间(DOR)、PFS、无事件生存期(EFS)以及总生存期(OS)。探索性研究目的:探索与LP-168联合R-CHOP方案临床疗效相关的生物标志物;评估外周血微小残留病(MRD)与LP-168联合R-CHOP方案临床疗效及预后的关系。
[Translation] Primary objective: To evaluate the safety, tolerability, dose-limiting toxicity (DLT), and pharmacokinetic (PK) characteristics of LP-168 combined with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, prednisone) in patients with B-cell lymphoma, and to determine the maximum tolerated dose (MTD) and phase III recommended dose (RP3D) of the combination regimen. Secondary objective: To evaluate the preliminary efficacy of LP-168 combined with R-CHOP in the treatment of patients with B-cell lymphoma, including but not limited to overall response rate (ORR), complete response rate (CRR), duration of response (DOR), PFS, event-free survival (EFS), and overall survival (OS). Exploratory study objectives: To explore biomarkers associated with the clinical efficacy of LP-168 combined with R-CHOP; to evaluate the relationship between peripheral blood minimal residual disease (MRD) and the clinical efficacy and prognosis of LP-168 combined with R-CHOP.
The Mass Balance Study of [14C]LP-168 in Chinese Healthy Subjects
This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi [14C]LP-168 in healthy subjects.
100 Clinical Results associated with Rocbrutinib
100 Translational Medicine associated with Rocbrutinib
100 Patents (Medical) associated with Rocbrutinib
100 Deals associated with Rocbrutinib