Delving into the Latest Updates on Junmeng Biosciences Co Ltd with Synapse

Overview

I期：评估JS004注射液单药及联合特瑞普利单抗不同剂量水平治疗复发或转移性HNC的安全性和耐受性。 II期：依据实体瘤疗效评价指标1.1版（RECIST 1.1）评估的客观缓解率（ORR），评估JS004注射液单药及联合特瑞普利单抗治疗复发或转移性HNC的有效性。

[Translation]

Phase I: Evaluate the safety and tolerability of JS004 injection alone and in combination with toripalimab at different dose levels in the treatment of recurrent or metastatic HNC. Phase II: Evaluate the effectiveness of JS004 injection alone and in combination with toripalimab in the treatment of recurrent or metastatic HNC based on the objective response rate (ORR) assessed by RECIST 1.1.

Start Date25 Jun 2021

Sponsor / Collaborator

Shanghai Junshi Bioengineering Co., Ltd.

[+3]

CTR20210103

/ RecruitingPhase 1

重组人源化抗BTLA单克隆抗体（JS004）注射液在晚期实体瘤患者中安全性、耐受性和药代动力学的I期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of recombinant humanized anti-BTLA monoclonal antibody (JS004) injection in patients with advanced solid tumors

评价JS004注射液单药及联合特瑞普利单抗在晚期实体瘤患者中的安全性和耐受性；确定JS004注射液单药及联合特瑞普利单抗治疗晚期实体瘤患者的最大耐受剂量（MTD）/推荐扩展剂量（RDE）。

[Translation]

To evaluate the safety and tolerability of JS004 injection alone and in combination with toripalimab in patients with advanced solid tumors; To determine the maximum tolerated dose (MTD)/recommended dose expansion (RDE) of JS004 injection alone and in combination with toripalimab in patients with advanced solid tumors.

Start Date12 Apr 2021

Sponsor / Collaborator

Shanghai Junshi Bioengineering Co., Ltd.

[+3]

CTR20200192

/ RecruitingPhase 3

特瑞普利单抗联合贝伐珠单抗对比索拉非尼一线治疗晚期肝细胞癌的安全性和有效性的随机、开放、多中心III期研究

[Translation] A randomized, open-label, multicenter phase III study on the safety and efficacy of toripalimab combined with bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma

比较特瑞普利单抗联合贝伐珠单抗与索拉非尼一线治疗晚期肝细胞癌的总生存期（OS）及由独立影像评审委员会根据RECIST v1.1标准评估的无进展生存期（PFS）。

[Translation]

To compare the overall survival (OS) and progression-free survival (PFS) assessed by an independent imaging review committee according to RECIST v1.1 criteria between toripalimab plus bevacizumab and sorafenib as first-line treatment for advanced hepatocellular carcinoma.

Start Date25 Feb 2021

Sponsor / Collaborator