[Translation] An open-label, multicenter, phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of PZH2113 capsules in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, primarily diffuse large B-cell lymphoma.
Part A1/A2主要目的:评价PZH2113胶囊在以DLBCL为主的r/r B-NHL受试者中的安全性和耐受性,确定MTD或MAD以及RD。次要目的:评价PZH2113胶囊单次和多次口服给药后的PK特征和PD指标的变化,血药浓度对QT/QTc间期的影响,以及初步抗肿瘤疗效。探索性目的:探索口服给药后可能的代谢产物及代谢途径。
Part B主要目的:评价PZH2113胶囊在MYD88MT的以DLBCL为主的r/r B-NHL受试者中的初步抗肿瘤疗效。次要目的:评价PZH2113胶囊在MYD88MT的以DLBCL为主的r/r B-NHL受试者中的安全性、多次口服给药后的PK特征和PD指标的变化,其他抗肿瘤疗效,以及食物对PK的影响。
[Translation] Part A1/A2 Primary Objective: To evaluate the safety and tolerability of PZH2113 capsules in patients with recurrent/r B-NHL predominantly composed of DLBCL, and to determine the mean toxicity (MTD) or mean toxicity (MAD) and recurrent disease (RD). Secondary Objective: To evaluate changes in pharmacokinetic (PK) characteristics and PD indices after single and multiple oral administrations of PZH2113 capsules, the effect of plasma drug concentration on the QT/QTc interval, and preliminary antitumor efficacy. Exploratory Objective: To explore possible metabolites and metabolic pathways after oral administration.
Part B Primary Objective: To evaluate the preliminary antitumor efficacy of PZH2113 capsules in patients with recurrent/r B-NHL predominantly composed of DLBCL at MYD88MT. Secondary Objective: To evaluate the safety of PZH2113 capsules in patients with recurrent/r B-NHL predominantly composed of DLBCL at MYD88MT, changes in PK characteristics and PD indices after multiple oral administrations, other antitumor efficacy, and the effect of food on PK in patients with recurrent/r B-NHL predominantly composed of DLBCL at MYD88MT.