Delving into the Latest Updates on SG404 with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Target

Mechanism

CD47 inhibitors(Cluster of differentiation 47 inhibitors), PHD2 inhibitors(egl-9 family hypoxia inducible factor 1 inhibitors)

Therapeutic Areas

NeoplasmsHemic and Lymphatic Diseases

Active Indication

Hematologic NeoplasmsSolid tumorAdvanced cancer

Inactive Indication-

Originator Organization

Hangzhou Shangjian Biotechnology Co., Ltd.Startup

Active Organization

Hangzhou Shangjian Biotechnology Co., Ltd.StartupZhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

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主要目的： 1) 评价注射用SG404在晚期恶性肿瘤患者中的安全性和耐受性。 2) 确定注射用SG404静脉给药在晚期恶性肿瘤患者中的剂量限制性毒性（DLT）和最大耐受剂量（MTD），为II期临床试验给药方案和给药剂量提供依据。次要目的： 1) 评价注射用SG404在晚期恶性肿瘤患者中的药代动力学特征。 2) 评价注射用SG404在晚期恶性肿瘤患者中的药效动力学特征。 3) 评价注射用SG404在晚期恶性肿瘤患者中的免疫原性。 4) 初步评价注射用SG404在晚期恶性肿瘤患者中的疗效。探索性目的：探索肿瘤组织中潜在预测注射用SG404疗效的生物标志物。

[Translation]

Primary objectives: 1) To evaluate the safety and tolerability of SG404 for injection in patients with advanced malignant tumors. 2) To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of intravenous SG404 for injection in patients with advanced malignant tumors, and to provide a basis for the dosing regimen and dosage of Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of SG404 for injection in patients with advanced malignant tumors. 2) To evaluate the pharmacodynamic characteristics of SG404 for injection in patients with advanced malignant tumors. 3) To evaluate the immunogenicity of SG404 for injection in patients with advanced malignant tumors. 4) To preliminarily evaluate the efficacy of SG404 for injection in patients with advanced malignant tumors. Exploratory objectives: To explore biomarkers in tumor tissues that may potentially predict the efficacy of SG404 for injection.

Start Date07 Jan 2021

Sponsor / Collaborator

Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.

100 Clinical Results associated with SG404

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100 Translational Medicine associated with SG404

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100 Patents (Medical) associated with SG404

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100 Deals associated with SG404

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 3	-	Hangzhou Shangjian Biotechnology Co., Ltd.Startup	-
Solid tumor	Phase 3	-	Hangzhou Shangjian Biotechnology Co., Ltd.Startup	-
Advanced cancer	Phase 1	CN	Zhongsheng Shangjian Biomedical (Hangzhou) Co., Ltd.	07 Jan 2021