Delving into the Latest Updates on SIM0348 with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

Target

Mechanism

CD112R antagonists(Transmembrane protein PVRIG antagonists), TIGIT inhibitors(T cell immunoglobulin and ITIM domains inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmSolid tumor

Inactive Indication-

Originator Organization

Simcere Pharmaceutical Group Ltd.

Active Organization

Jiangsu Simcere Pharmaceutical Co., Ltd.Shanghai Xianxiang Medical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).

Start Date01 Apr 2023

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

CTR20230479 / RecruitingPhase 1

评价SIM0348在晚期实体瘤受试者中的安全性、耐受性、药代动力学和初步抗肿瘤活性的首次人体、开放性、剂量递增I期研究

[Translation] A first-in-human, open-label, dose-escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SIM0348 in subjects with advanced solid tumors

评估 SIM0348 单药在晚期实体瘤受试者中的安全性、耐受性，并评价最大耐受剂量（MTD）和推荐剂量(RD)、药代动力学 (PK) 特性、免疫原性，并初步评价 SIM0348 的抗肿瘤活性。探索肿瘤组织和外周血中潜在预测SIM0348单药抗肿瘤活性的生物标志物

[Translation]

To evaluate the safety and tolerability of SIM0348 monotherapy in subjects with advanced solid tumors, and to assess the maximum tolerated dose (MTD) and recommended dose (RD), pharmacokinetic (PK) properties, immunogenicity, and preliminarily evaluate the anti-tumor activity of SIM0348. To explore biomarkers in tumor tissue and peripheral blood that can potentially predict the anti-tumor activity of SIM0348 monotherapy

Start Date22 Mar 2023

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

100 Clinical Results associated with SIM0348

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100 Translational Medicine associated with SIM0348

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100 Patents (Medical) associated with SIM0348

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100 Deals associated with SIM0348

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	22 Mar 2023
Solid tumor	IND Approval	CN	Shanghai Xianxiang Medical Technology Co., Ltd.	12 Oct 2023