多中心、开放、剂量递增和扩大入组评价重组抗PD-L1和TGF-β双功能融合蛋白注射液在晚期复发或难治性恶性实体瘤参与者中的安全性、耐受性和初步疗效的Ⅰ期临床研究
[Translation] A multicenter, open-label, dose-escalation, and expanded-enrollment phase I clinical study evaluating the safety, tolerability, and preliminary efficacy of recombinant anti-PD-L1 and TGF-β bifunctional fusion protein injection in participants with advanced relapsed or refractory malignant solid tumors.
[Translation] See attachment for details
一项评估HL17在复发或难治性多发性骨髓瘤受试者中的安全性、耐受性、药代动力学和初步有效性的I期、开放标签、多中心研究
[Translation] A phase I, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of HL17 in patients with relapsed or refractory multiple myeloma.
主要目的:
● 评估 HL17 在复发或难治性多发性骨髓瘤患者中的安全性和耐受性
次要目的:
● 评估 HL17 在复发或难治性多发性骨髓瘤患者中的初步抗肿瘤活性
● 评估 HL17 在复发或难治性多发性骨髓瘤患者中的药代动力学
(PK)特征
● 评估 HL17 在复发或难治性多发性骨髓瘤患者中的免疫原性
● 探索 HL17 在复发或难治性多发性骨髓瘤患者中的生物标志物
[Translation] Primary Objectives:
● To evaluate the safety and tolerability of HL17 in patients with relapsed or refractory multiple myeloma.
Secondary Objectives:
● To evaluate the preliminary antitumor activity of HL17 in patients with relapsed or refractory multiple myeloma.
● To evaluate the pharmacokinetic (PK) characteristics of HL17 in patients with relapsed or refractory multiple myeloma.
● To evaluate the immunogenicity of HL17 in patients with relapsed or refractory multiple myeloma.
● To explore biomarkers of HL17 in patients with relapsed or refractory multiple myeloma.
/ Active, not recruitingPhase 1 单中心、随机、双盲、单剂量、平行比较地舒单抗注射液(HL05-2)与普罗力®在健康男性参与者中药代动力学相似性和安全性的Ⅰ期临床研究
[Translation] A single-center, randomized, double-blind, single-dose, parallel phase I clinical study comparing the pharmacokinetic similarity and safety of denosumab injection (HL05-2) and Prolix® in healthy male participants
比较地舒单抗注射液(HL05-2)与普罗力®在健康男性参与者中药代动力学相似性和安全性。
[Translation] To compare the pharmacokinetic similarity and safety of denosumab injection (HL05-2) and Prolix® in healthy male participants.
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