Delving into the Latest Updates on Exenokine-21 with Synapse

This is an open-label, single-center, single-arm phase Ib clinical trial. The aim of this study is to assess the safety and efficacy of JS014 in combination with Toripalimab and transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma (HCC). The primary endpoint is the safety and tolerability, while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), time to progression (TPP), progression-free survival (PFS), and overall survival (OS).

Start Date10 Jul 2025

Sponsor / Collaborator

Xiangya Hospital Central South University

[+1]

NCT05296772

/ RecruitingPhase 1

A Phase 1 Study of JS014, a Recombinant Fusion Protein of Interleukin-21 and Humanized Anti-human Serum Albumin VHH Antibody as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Cancer

This phase 1, first-in-human study uses a BOIN design to assess the safety and potential efficacy of JS014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer.

Start Date28 Feb 2022

Sponsor / Collaborator

ANWITA BIOSCIENCES INC

[+1]

CTR20213180

/ TerminatedPhase 1

重组白介素 21-抗人血清白蛋白纳米抗体融合蛋白（JS014）单药及联合特瑞普利单抗在晚期肿瘤患者中的安全性、耐受性、药代动力学和初步疗效的 I 期临床研究

[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant interleukin-21-anti-human serum albumin nanobody fusion protein (JS014) alone and in combination with toripalimab in patients with advanced tumors

主要目的：评价 JS014 单药及联合特瑞普利单抗在晚期肿瘤患者中的安全性和耐受性；确定JS014单药及联合特瑞普利单抗在晚期肿瘤患者中的最大耐受剂量（MTD）和II期推荐剂量（RP2D）。次要目的：评价 JS014 单药及联合特瑞普利单抗在晚期肿瘤患者中的药代动力学（PK）特征；评价 JS014 单药及联合特瑞普利单抗在晚期肿瘤患者中的免疫原性；初步评价 JS014 单药及联合特瑞普利单抗治疗晚期肿瘤的有效性。评价 JS014 单药及联合特瑞普利单抗的药效学特征；探索性目的：探索相关生物标志物与临床疗效的关系。

[Translation]

Primary objective: To evaluate the safety and tolerability of JS014 alone and in combination with toripalimab in patients with advanced tumors; To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of JS014 alone and in combination with toripalimab in patients with advanced tumors. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of JS014 alone and in combination with toripalimab in patients with advanced tumors; To evaluate the immunogenicity of JS014 alone and in combination with toripalimab in patients with advanced tumors; To preliminarily evaluate the effectiveness of JS014 alone and in combination with toripalimab in the treatment of advanced tumors. To evaluate the pharmacodynamic characteristics of JS014 alone and in combination with toripalimab; Exploratory objective: To explore the relationship between relevant biomarkers and clinical efficacy.

Start Date06 Jan 2022

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

100 Clinical Results associated with Exenokine-21

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100 Translational Medicine associated with Exenokine-21

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100 Patents (Medical) associated with Exenokine-21

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100 Deals associated with Exenokine-21

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 2	China	Shanghai Junshi Biosciences Co., Ltd.	23 Jan 2024
Lymphoma	Phase 1	Taiwan Province	ANWITA BIOSCIENCES INC	28 Feb 2022
Lymphoma	Phase 1	Taiwan Province	Shanghai Junshi Biosciences Co., Ltd.	28 Feb 2022
Solid tumor	Phase 1	Taiwan Province	ANWITA BIOSCIENCES INC	28 Feb 2022
Solid tumor	Phase 1	Taiwan Province	Shanghai Junshi Biosciences Co., Ltd.	28 Feb 2022
Advanced cancer	Phase 1	China	Shanghai Junshi Biosciences Co., Ltd.	06 Jan 2022

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