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Phase II Clinical Trial on the Safety and Efficacy of PSMA-Targeted Fluorescent Contrast Agent DGPR1008 for Intraoperative Imaging in Robot-Assisted Radical Prostatectomy
一项评估 PSMA 靶向荧光造影剂 DGPR1008 用于前列腺 癌术中成像的安全性、耐受性和药代动力学的临床 I /II期 研究
[Translation] A Phase I/II study evaluating the safety, tolerability, and pharmacokinetics of the PSMA-targeted fluorescent contrast agent DGPR1008 for intraoperative imaging of prostate cancer
Ⅰ期阶段:
主要研究目的:
评估DGPR1008在健康受试者中单次给药的安全性、耐受性和药代动力学特征。
次要研究目的: 根据安全性和药代动力学结果评估DGPR1008的最大耐受剂量(MTD)和临床Ⅱ期推荐剂量(RP2D)。
Ⅱ期阶段:
主要研究目的:
评估DGPR1008在患者中单次给药的安全性和药代动力学特征。
次要研究目的:
评估DGPR1008联合近红外荧光成像设备检测在患者手术中的成像的有效性。
[Translation] Phase I stage:
Main study objectives:
To evaluate the safety, tolerability and pharmacokinetic characteristics of a single dose of DGPR1008 in healthy subjects.
Secondary study objectives: To evaluate the maximum tolerated dose (MTD) and clinical phase II recommended dose (RP2D) of DGPR1008 based on safety and pharmacokinetic results.
Phase II stage:
Main study objectives:
To evaluate the safety and pharmacokinetic characteristics of a single dose of DGPR1008 in patients.
Secondary study objectives:
To evaluate the effectiveness of imaging in patients during surgery using DGPR1008 combined with near-infrared fluorescence imaging equipment.
/ Not yet recruitingPhase 2 PSMA靶向荧光造影剂DGPR1008用于机器人辅助前列腺根治术术中成像的安全性、有效性的临床Ⅱ期研究
[Translation] A Phase II clinical study on the safety and efficacy of the PSMA-targeted fluorescent contrast agent DGPR1008 for intraoperative imaging in robot-assisted radical prostatectomy.
主要研究目的:
评估DGPR1008联合机器人手术控制系统,在机器人辅助前列腺根治术(Robot-Assisted Radical Prostatectomy RARP)术中荧光成像的有效性。
次要研究目的:
评估DGPR1008联合近红外荧光成像设备,在前列腺根治术后经组织病理学检测切缘阳性(PSM)的比率;
评估DGPR1008在患者中单次给药的安全性。
探索性研究目的:
评估肿瘤背景比(TBR)。
[Translation] Primary Study Objective: To evaluate the effectiveness of DGPR1008 in conjunction with a robotic surgical control system for fluorescence imaging during robot-assisted radical prostatectomy (RARP).
Secondary Study Objectives: To evaluate the rate of positive surgical margins (PSM) detected by histopathological examination after RARP using DGPR1008 in conjunction with near-infrared fluorescence imaging; to evaluate the safety of a single dose of DGPR1008 in patients.
Exploratory Study Objective: To evaluate the tumor background ratio (TBR).
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