[Translation] An open, multicenter phase Ib/II clinical study of HRS2398 combined with adebelimumab injection in the treatment of advanced solid tumors
主要研究目的:
评价HRS2398联合阿得贝利单抗注射液治疗晚期实体瘤患者的耐受性;
确定HRS2398联合阿得贝利单抗注射液治疗晚期实体瘤患者的 II 期临床推荐剂量(RP2D);
评价HRS2398联合阿得贝利单抗注射液治疗晚期实体瘤患者的有效性。
次要研究目的:
评价HRS2398联合阿得贝利单抗注射液治疗晚期实体瘤患者的有效性(针对剂量探索阶段);
评价HRS2398联合阿得贝利单抗注射液治疗晚期实体瘤患者的安全性、药代动力学(PK)特征; 评价阿得贝利单抗的免疫原性特征。
探索性研究目的:
评价生物标志物与疗效的相关性;
探索 HRS2398 对晚期恶性肿瘤患者 QT 间期的影响; 探索 HRS2398 在晚期恶性肿瘤患者血浆中的药物代谢特征。
[Translation] Main study objectives:
To evaluate the tolerability of HRS2398 combined with Adebelimumab injection in patients with advanced solid tumors;
To determine the recommended Phase II clinical dose (RP2D) of HRS2398 combined with Adebelimumab injection in patients with advanced solid tumors;
To evaluate the efficacy of HRS2398 combined with Adebelimumab injection in patients with advanced solid tumors.
Secondary study objectives:
To evaluate the efficacy of HRS2398 combined with Adebelimumab injection in patients with advanced solid tumors (for the dose exploration phase);
To evaluate the safety and pharmacokinetic (PK) characteristics of HRS2398 combined with Adebelimumab injection in patients with advanced solid tumors;
To evaluate the immunogenicity characteristics of Adebelimumab.
Exploratory study objectives:
To evaluate the correlation between biomarkers and efficacy;
To explore the effect of HRS2398 on the QT interval of patients with advanced malignant tumors;
To explore the drug metabolism characteristics of HRS2398 in the plasma of patients with advanced malignant tumors.