Delving into the Latest Updates on Shanghai Junshi Bioengineering Co., Ltd. with Synapse

Overview

[Translation] A multicenter, open, randomized, controlled, phase III clinical study comparing the pharmacokinetic characteristics, efficacy, and safety of toripalimab injection (for subcutaneous injection) (JS001sc) and toripalimab injection (JS001) combined with standard chemotherapy as first-line treatment for recurrent or metastatic non-squamous non-small cell lung cancer

在复发或转移性非鳞非小细胞肺癌（NSCLC）患者中评估JS001sc对比JS001的药代动力学、安全性及疗效

[Translation]

To evaluate the pharmacokinetics, safety, and efficacy of JS001sc versus JS001 in patients with recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC)

Start Date13 Jun 2024

Sponsor / Collaborator

Shanghai Junshi Bioengineering Co., Ltd.

[+1]

CTR20210976

/ CompletedPhase 1

重组人源化抗BTLA单克隆抗体（JS004）在晚期头颈癌患者的I/II期临床研究

[Translation] Phase I/II clinical study of recombinant humanized anti-BTLA monoclonal antibody (JS004) in patients with advanced head and neck cancer

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]

100 Clinical Results associated with Shanghai Junshi Bioengineering Co., Ltd.

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100 Deals associated with Shanghai Junshi Bioengineering Co., Ltd.

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100 Translational Medicine associated with Shanghai Junshi Bioengineering Co., Ltd.

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