[Translation] A multicenter, open-label, phase Ib/II clinical study evaluating the efficacy, safety/tolerability and pharmacokinetics of GFH009 in patients with relapsed or refractory peripheral T-cell lymphoma
Ib期:主要目的:对GFH009单药在目前最高剂量下治疗复发或难治PTCL受试者进行安全性确认,综合FIH研究中所有数据最终确定II期推荐剂量(RP2D)。次要目的:评估GFH009单药治疗复发或难治PTCL受试者的疗效,评价GFH009的药代动力学(PK)特征。
II期:主要目的:评估GFH009单药治疗复发或难治PTCL受试者的疗效。次要目的:使用其他疗效指标评估GFH009单药治疗PTCL的疗效,进一步评估GFH009单药治疗复发或难治PTCL受试者的安全性,评价GFH009的PK特征。
[Translation] Phase Ib: Main purpose: To confirm the safety of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects at the current highest dose, and to finally determine the phase II recommended dose (RP2D) based on all the data in the FIH study. Secondary objectives: To evaluate the efficacy of GFH009 monotherapy in subjects with relapsed or refractory PTCL, and to evaluate the pharmacokinetic (PK) characteristics of GFH009.
Phase II: Main purpose: To evaluate the efficacy of GFH009 monotherapy in subjects with relapsed or refractory PTCL. Secondary objectives: To use other efficacy indicators to evaluate the efficacy of GFH009 monotherapy in PTCL, to further evaluate the safety of GFH009 monotherapy in subjects with relapsed or refractory PTCL, and to evaluate the PK characteristics of GFH009.