[Translation] A Phase I/II clinical study evaluating the safety, tolerability, pharmacokinetics, and efficacy of HP-001 capsules combined with dexamethasone in patients with relapsed or refractory multiple myeloma
主要目的:评估 HP-001 胶囊联合地塞米松在复发难治多发性骨髓瘤(MM)中的安全性、耐受性。次要目的:评估 HP-001 胶囊联合地塞米松在复发难治 MM 中的药代动力学(PK)特征。评估 HP-001 胶囊联合地塞米松在复发难治 MM 中的有效性。探索目的:评估与抗肿瘤活性可能有关的药效学(PD)生物标志物。
[Translation] Primary Objective: To evaluate the safety and tolerability of HP-001 capsules combined with dexamethasone in patients with relapsed or refractory multiple myeloma (MM). Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of HP-001 capsules combined with dexamethasone in patients with relapsed or refractory MM. To evaluate the efficacy of HP-001 capsules combined with dexamethasone in patients with relapsed or refractory MM. Exploratory Objective: To evaluate pharmacodynamic (PD) biomarkers potentially associated with antitumor activity.