评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中的安全性和耐受性、药代动力学特征、以及有效性的Ⅰb期临床研究
[Translation] A phase Ib clinical study to evaluate the safety and tolerability, pharmacokinetic characteristics, and efficacy of Besanostat combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma
1.评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中的安全性和耐受性;探索剂量限制性毒性(DLT)和最大耐受剂量(MTD);确定Ⅱ期推荐给药剂量(RP2D),为后续的临床研究提供依据。
2.评价倍赛诺他片联合伊沙佐米和地塞米松在复发或难治性多发性骨髓瘤患者中有效性,以及倍赛诺他和代谢物M1及伊沙佐米的药代动力学(PK)特征。
3.评价倍赛诺他片联合伊沙佐米和地塞米松治疗复发或难治性多发性骨髓瘤患者时的药效动力学(PD)特征,以及微小残留病(MRD)。
[Translation] 1. Evaluate the safety and tolerability of Besanostat tablets combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma; explore the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD); determine the recommended dose (RP2D) for phase II to provide a basis for subsequent clinical studies.
2. Evaluate the efficacy of Besanostat tablets combined with ixazomib and dexamethasone in patients with relapsed or refractory multiple myeloma, as well as the pharmacokinetic (PK) characteristics of Besanostat and metabolites M1 and ixazomib.
3. Evaluate the pharmacodynamic (PD) characteristics of Besanostat tablets combined with ixazomib and dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma, as well as minimal residual disease (MRD).
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