Delving into the Latest Updates on DXC-009 with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Target-

Mechanism-

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [1]

Active Indication

Multiple Myeloma

Inactive Indication-

Originator Organization

Hangzhou DAC Biotechnology Co., Ltd.

Active Organization

Hangzhou DAC Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Structure

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评价DXC009 在难治复发性多发性骨髓瘤患者中的安全性和耐受性，确定DXC009 在RRMM 患者中的最大耐受剂量（MTD）和剂量限制性毒性（DLT），确定Ⅱ期临床试验推荐剂量（RP2D）。评价DXC009、抗总抗体及Tub268-cys、Tub268-cys-iso 在RRMM 患者体内的药代动力学（PK）特征；评价DXC009 在RRMM 患者中的免疫原性；初步评价DXC009 在RRMM 患者中的临床疗效；探讨患者基线骨髓靶点表达、基线血清可溶性靶点水平及治疗后血清可溶性靶点水平与治疗效果的相关性。

[Translation]

To evaluate the safety and tolerability of DXC009 in patients with refractory relapsed multiple myeloma, determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of DXC009 in RRMM patients, and determine the recommended dose (RP2D) for Phase II clinical trials. To evaluate the pharmacokinetic (PK) characteristics of DXC009, anti-total antibody, Tub268-cys, and Tub268-cys-iso in RRMM patients; to evaluate the immunogenicity of DXC009 in RRMM patients; to preliminarily evaluate the clinical efficacy of DXC009 in RRMM patients; to explore the correlation between the patient's baseline bone marrow target expression, baseline serum soluble target level, and serum soluble target level after treatment and the treatment effect.

Start Date-

Sponsor / Collaborator

Hangzhou DAC Biotechnology Co., Ltd.

100 Clinical Results associated with DXC-009

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100 Translational Medicine associated with DXC-009

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100 Patents (Medical) associated with DXC-009

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100 Deals associated with DXC-009

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