[Translation] A Phase Ib/II clinical study evaluating the safety, tolerability, and preliminary efficacy of injectable SG2918 in patients with relapsed/refractory multiple myeloma.
Ib期研究阶段 1.主要目的:1)安全性和耐受性;
2.次要目的:1)评估SG2918在复发/难治性多发性骨髓瘤患者中的PK和PD特征;2)评估SG2918的免疫原性;3)评价SG2918在复发/难治性多发性骨髓瘤患者治疗的初步抗肿瘤疗效。
II期研究阶段
1. 主要目的:1) 安全性和耐受性;2)确定SG2918在复发/难治性多发性骨髓瘤患者中的RP2D;3)评价SG2918单药治疗复发/难治性多发性骨髓瘤的初步抗肿瘤活性。
2.次要目的:
1) 评价SG2918在复发/难治性多发性骨髓瘤患者治疗的有效性(PFS、MRD阴性率等)2)评估SG2918在复发/难治性多发性骨髓瘤患者中的药代动力学(PK)和PD特征;
3) 评估SG2918的免疫原性。
[Translation] Phase Ib Study: 1. Primary Objectives: 1) Safety and tolerability;
2. Secondary Objectives: 1) To evaluate the PK and PD characteristics of SG2918 in patients with relapsed/refractory multiple myeloma; 2) To evaluate the immunogenicity of SG2918; 3) To evaluate the preliminary antitumor efficacy of SG2918 in the treatment of patients with relapsed/refractory multiple myeloma.
Phase II Study: 1. Primary Objectives: 1) Safety and tolerability; 2) To determine the RP2D of SG2918 in patients with relapsed/refractory multiple myeloma; 3) To evaluate the preliminary antitumor activity of SG2918 as monotherapy in patients with relapsed/refractory multiple myeloma. 2. Secondary objectives:
1) To evaluate the efficacy of SG2918 in the treatment of patients with relapsed/refractory multiple myeloma (PFS, MRD negativity rate, etc.);
2) To assess the pharmacokinetic (PK) and PD characteristics of SG2918 in patients with relapsed/refractory multiple myeloma;
3) To assess the immunogenicity of SG2918.