[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: Primary purpose: To confirm the safety of GFH009 monotherapy at the highest current dose in the treatment of relapsed or refractory PTCL subjects, and to determine the Phase II recommended dose (RP2D) based on all data from the FIH study. Secondary purpose: To evaluate the efficacy of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects, and to evaluate the pharmacokinetic (PK) characteristics of GFH009.
Phase II: Primary purpose: To evaluate the efficacy of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects. Secondary purpose: To evaluate the efficacy of GFH009 monotherapy in the treatment of PTCL using other efficacy indicators, to further evaluate the safety of GFH009 monotherapy in the treatment of relapsed or refractory PTCL subjects, and to evaluate the PK characteristics of GFH009.