Delving into the Latest Updates on SYS6051 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms-

Target

Top I x tissue factor

Action

inhibitors

Mechanism

TOP1 inhibitors(DNA topoisomerase I inhibitors), tissue factor inhibitors(Tissue factor inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmNeoplasms

Inactive Indication-

Originator Organization

CSPC Pharmaceutical Group Ltd.

Active Organization

CSPC Pharmaceutical Group Ltd.CSPC Megalith Biopharmaceutial Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure/Sequence

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剂量递增与回填阶段主要目的：评估SYS6051治疗晚期实体瘤参与者的安全性和耐受性。确定SYS6051的MTD（如有）和RP2D。次要目的：评估SYS6051在晚期实体瘤参与者中的PK特征。评估SYS6051在晚期实体瘤参与者中的免疫原性。评估SYS6051的初步抗肿瘤活性。队列扩展阶段主要目的：评估SYS6051在RP2D剂量下治疗晚期实体瘤的抗肿瘤活性。次要目的：评估SYS6051在晚期实体瘤中的抗肿瘤活性。评估SYS6051在晚期实体瘤中的安全性和耐受性。评估SYS6051在晚期实体瘤参与者中的PK特征。评估SYS6051在晚期实体瘤参与者中的免疫原性。

[Translation]

Dose Escalation and Backfill Phase Primary Objective: To evaluate the safety and tolerability of SYS6051 in participants with advanced solid tumors. To determine the MTD (if applicable) and RP2D of SYS6051. Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of SYS6051 in participants with advanced solid tumors. To evaluate the immunogenicity of SYS6051 in participants with advanced solid tumors. To evaluate the preliminary antitumor activity of SYS6051. Cohort Expansion Phase Primary Objective: To evaluate the antitumor activity of SYS6051 at RP2D doses in the treatment of advanced solid tumors. Secondary Objective: To evaluate the antitumor activity of SYS6051 in advanced solid tumors. To evaluate the safety and tolerability of SYS6051 in advanced solid tumors. To evaluate the PK characteristics of SYS6051 in participants with advanced solid tumors. To evaluate the immunogenicity of SYS6051 in participants with advanced solid tumors.

Start Date-

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with SYS6051

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100 Translational Medicine associated with SYS6051

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100 Patents (Medical) associated with SYS6051

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100 Deals associated with SYS6051

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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	China	CSPC Megalith Biopharmaceutial Co., Ltd.	13 May 2026
Neoplasms	Preclinical	China	CSPC Pharmaceutical Group Ltd.	29 Apr 2025

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Clinical Result

Indication

Phase

Evaluation

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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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