Delving into the Latest Updates on SYS6045 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

SYS6045

Target-

Action-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid NeoplasmHER2 Positive Solid Tumors

Inactive Indication-

Originator Organization

CSPC Megalith Biopharmaceutial Co., Ltd.

Active Organization

CSPC Megalith Biopharmaceutial Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

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This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study. It aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of SYS6045 in patients with HER2-positive, expressing, or mutated advanced solid tumors.

Start Date11 Aug 2025

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

CTR20252942

/ Not yet recruitingPhase 1/2

一项评估SYS6045在HER2阳性、表达或突变的晚期恶性实体瘤中的安全性、耐受性、药代动力学和初步有效性的多中心、开放性Ⅰ/Ⅱ期临床研究

[Translation] A multicenter, open-label Phase I/II clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of SYS6045 in HER2-positive, expressing, or mutated advanced malignant solid tumors

I期主要目的为评估SYS6045在HER2阳性、表达或突变的晚期恶性实体瘤中的安全性和耐受性，确定推荐的II期剂量（RP2D）。 II期主要目的为评估SYS6045在RP2D下治疗晚期实体瘤的抗肿瘤活性。

[Translation]

The primary objective of the Phase I study is to evaluate the safety and tolerability of SYS6045 in patients with HER2-positive, HER2-expressing, or HER2-mutated advanced malignant solid tumors and to determine the recommended Phase II dose (RP2D). The primary objective of the Phase II study is to evaluate the anti-tumor activity of SYS6045 in patients with advanced solid tumors at the RP2D.

Start Date-

Sponsor / Collaborator

CSPC Megalith Biopharmaceutial Co., Ltd.

100 Clinical Results associated with SYS6045

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100 Translational Medicine associated with SYS6045

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100 Patents (Medical) associated with SYS6045

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100 Deals associated with SYS6045

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	China	CSPC Megalith Biopharmaceutial Co., Ltd.	11 Aug 2025
HER2 Positive Solid Tumors	Phase 2	China	CSPC Megalith Biopharmaceutial Co., Ltd.	01 Aug 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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