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Clinical Trials associated with HBT-708 / Not yet recruitingPhase 1 评价 HBT-708 单药在晚期实体瘤患者中的安全性、耐受性和初步抗肿瘤活性的 I 期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability and preliminary anti-tumor activity of HBT-708 monotherapy in patients with advanced solid tumors
主要目的:
评估HBT-708在晚期实体瘤患者中的安全性和耐受性、剂量限制性毒性(DLT),确定最大耐受剂量(MTD)或未达到MTD情况下的最大给药剂量(MAD),确定II期推荐剂量(RP2D)。
次要目的:
评价HBT-708在晚期实体瘤患者中的药代动力学(PK)特征。 评价HBT-708在晚期实体瘤患者中的药效学(PD)特征。
评估HBT-708在晚期实体瘤患者中的免疫原性。 评估HBT-708在晚期实体瘤中的初步抗肿瘤活性。 探索性目的:
评估肿瘤标本中PD-L1表达与疗效的相关性。
[Translation] Primary objectives:
Evaluate the safety and tolerability of HBT-708 in patients with advanced solid tumors, dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or the maximum dose (MAD) when the MTD is not reached, and determine the recommended dose for Phase II (RP2D).
Secondary objectives:
Evaluate the pharmacokinetic (PK) characteristics of HBT-708 in patients with advanced solid tumors. Evaluate the pharmacodynamic (PD) characteristics of HBT-708 in patients with advanced solid tumors.
Evaluate the immunogenicity of HBT-708 in patients with advanced solid tumors. Evaluate the preliminary anti-tumor activity of HBT-708 in advanced solid tumors. Exploratory objectives:
Evaluate the correlation between PD-L1 expression and efficacy in tumor specimens.
100 Clinical Results associated with HBT-708
100 Translational Medicine associated with HBT-708
100 Patents (Medical) associated with HBT-708
100 Deals associated with HBT-708