[Translation] A multicenter phase I/II clinical study on the safety, tolerability, efficacy and pharmacokinetics of HBW-3210 capsules in Chinese patients with mature B-cell lymphoma
剂量爬坡阶段(I)1)主要目的:评估HBW-3210单药口服给药在B细胞淋巴瘤患者中的安全性和耐受性,确定最大耐受剂量(MTD)和剂量限制性毒性(DLT)。2)次要目的:评价HBW-3210在B细胞淋巴瘤患者的药代动力学特征。初步评估HBW-3210在B细胞淋巴瘤患者中的有效性。
扩展队列阶段(II)1)主要目的:评估HBW-3210在B细胞淋巴瘤患者的客观缓解率(ORR,即CR+PR)。2)次要目的:评价HBW-3210在B细胞淋巴瘤患者的药代动力学特征;评价HBW-3210在B细胞淋巴瘤患者中的安全性;评价HBW-3210在B细胞淋巴瘤患者中的其它有效性指标,例如起效时间(TTR)、缓解持续时间(DOR)、无进展生存期(PFS)、总生存期(OS)、部分缓解率(PR)、完全缓解率(CR)、疾病控制率(DCR)。
[Translation] Dose escalation phase (I) 1) Primary objective: To evaluate the safety and tolerability of oral monotherapy of HBW-3210 in patients with B-cell lymphoma, and to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). 2) Secondary objective: To evaluate the pharmacokinetic characteristics of HBW-3210 in patients with B-cell lymphoma. Preliminary evaluation of the efficacy of HBW-3210 in patients with B-cell lymphoma.
Expansion cohort phase (II) 1) Primary objective: To evaluate the objective response rate (ORR, i.e. CR+PR) of HBW-3210 in patients with B-cell lymphoma. 2) Secondary objectives: To evaluate the pharmacokinetic characteristics of HBW-3210 in patients with B-cell lymphoma; To evaluate the safety of HBW-3210 in patients with B-cell lymphoma; To evaluate other efficacy indicators of HBW-3210 in patients with B-cell lymphoma, such as time to onset of response (TTR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), partial response rate (PR), complete response rate (CR), and disease control rate (DCR).