Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项在晚期实体瘤患者中评价JR8603 的首次人体、开放性、剂量递增和扩展的研究
[Translation] A first-in-human, open-label, dose-escalation and expansion study evaluating JR8603 in patients with advanced solid tumors
一、剂量递增(第1部分)
主要目的:
评价JR8603 的安全性和耐受性;确定最大耐受剂量(MTD)和/II 期推荐剂量( RP2D )。
次要目的:
确定JR8603 在晚期实体瘤中的有效性;评估JR8603 的药代动力学(PK) 特征。
探索性目的:
通过血清和肿瘤组织中生物标志物的表达以及血清Legumain 水平评估ORR。 二、剂量扩展(第2部分)
主要目的:确定MTD/RP2D 下JR8603 的安全性和耐受性;评估各队列有效性的初步证据。
次要目的:进一步评估JR8603 的PK 特征;确定JR8603 在各队列的有效性。
探索性目的:通过血清和肿瘤组织中生物标志物的表达以及血清Legumain 水平评估ORR。
[Translation] I. Dose escalation (Part 1)
Primary objectives:
Evaluate the safety and tolerability of JR8603; determine the maximum tolerated dose (MTD) and/phase II recommended dose (RP2D).
Secondary objectives:
Determine the efficacy of JR8603 in advanced solid tumors; evaluate the pharmacokinetic (PK) characteristics of JR8603.
Exploratory objectives:
Evaluate ORR by the expression of biomarkers in serum and tumor tissues and serum Legumain levels. II. Dose expansion (Part 2)
Primary objectives: Determine the safety and tolerability of JR8603 under MTD/RP2D; evaluate the preliminary evidence of efficacy in each cohort.
Secondary objectives: Further evaluate the PK characteristics of JR8603; determine the efficacy of JR8603 in each cohort.
Exploratory objectives: Evaluate ORR by the expression of biomarkers in serum and tumor tissues and serum Legumain levels.
100 Clinical Results associated with Jiangsu Jiarui Biotechnology Co., Ltd.
0 Patents (Medical) associated with Jiangsu Jiarui Biotechnology Co., Ltd.
100 Deals associated with Jiangsu Jiarui Biotechnology Co., Ltd.
100 Translational Medicine associated with Jiangsu Jiarui Biotechnology Co., Ltd.