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Clinical Trials associated with HRS-2398An Open-label, Multi-center Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors
This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.
HRS2398联合阿得贝利单抗注射液治疗晚期实体肿瘤的开放、多中心Ⅰb/Ⅱ期临床研究
[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.
HRS2398在晚期恶性肿瘤患者中安全性、耐受性及药代动力学的I期临床研究
[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of HRS2398 in patients with advanced malignant tumors
主要目的:确定HRS2398单药在晚期恶性肿瘤患者中的剂量限制性毒性及最大耐受剂量,明确后续临床试验给药剂量和给药方案。
次要目的:评价HRS2398的安全性、有效性;分析HRS2398及其代谢产物药代动力学特征;探索HRS2398食物效应。
探索性研究目的:初步探索基因突变和蛋白表达状态与疗效的关系;分析基因突变与临床药效的关系及耐药机制。
[Translation] Main purpose: To determine the dose-limiting toxicity and maximum tolerated dose of HRS2398 monotherapy in patients with advanced malignant tumors, and to clarify the dosage and dosing regimen for subsequent clinical trials.
Secondary purpose: To evaluate the safety and efficacy of HRS2398; to analyze the pharmacokinetic characteristics of HRS2398 and its metabolites; to explore the food effect of HRS2398.
Exploratory study purpose: To preliminarily explore the relationship between gene mutation and protein expression status and efficacy; to analyze the relationship between gene mutation and clinical efficacy and drug resistance mechanism.
100 Clinical Results associated with HRS-2398
100 Translational Medicine associated with HRS-2398
100 Patents (Medical) associated with HRS-2398
100 Deals associated with HRS-2398