Delving into the Latest Updates on WBP-3425 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

WBP3425

Target

4-1BB

Action

agonists

Mechanism

4-1BB agonists(Tumor necrosis factor receptor superfamily member 9 agonists)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication

Colonic Cancer

Originator Organization

Wuxi Zhikang Hongyi Biological Technology Co Ltd

Active Organization

Wuxi Zhikang Hongyi Biological Technology Co Ltd

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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[Translation] An open, single-arm, non-randomized Phase I clinical trial: To evaluate the safety, tolerability, pharmacokinetic characteristics, and pharmacodynamic characteristics of WBP3425 in patients with advanced malignant solid tumors, and to preliminarily explore the anti-tumor activity of WBP3425

主要目的：评估WBP3425单药在晚期恶性实体瘤患者中的安全性和耐受性。探索WBP3425的最大耐受剂量(MTD)，确定II期临床试验推荐剂量(RP2D)。次要目的：评估 WBP3425单药在晚期恶性实体瘤患者中的药代动力学(PK)特征。评估 WBP3425单药在晚期恶性实体瘤患者中的免疫原性。评估 WBP3425单药的初步抗肿瘤活性。探索WBP3425药效动力学(PD)特征与安全和疗效的关系。

[Translation]

Primary objectives: Evaluate the safety and tolerability of WBP3425 monotherapy in patients with advanced malignant solid tumors. Explore the maximum tolerated dose (MTD) of WBP3425 and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: Evaluate the pharmacokinetic (PK) characteristics of WBP3425 monotherapy in patients with advanced malignant solid tumors. Evaluate the immunogenicity of WBP3425 monotherapy in patients with advanced malignant solid tumors. Evaluate the preliminary anti-tumor activity of WBP3425 monotherapy. Explore the relationship between the pharmacodynamic (PD) characteristics of WBP3425 and safety and efficacy.

Start Date03 Sep 2020

Sponsor / Collaborator

Wuxi Zhikang Hongyi Biological Technology Co Ltd

ChiCTR2100045310

/ RecruitingPhase 1

A phase 1, open-label, single-center trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity of WBP3425 in patients with advanced solid tumors

Start Date26 Aug 2020

Sponsor / Collaborator-

100 Clinical Results associated with WBP-3425

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100 Translational Medicine associated with WBP-3425

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100 Patents (Medical) associated with WBP-3425

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100 Deals associated with WBP-3425

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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	Wuxi Zhikang Hongyi Biological Technology Co Ltd	03 Sep 2020
Colonic Cancer	IND Application	China	Wuxi Zhikang Hongyi Biological Technology Co Ltd	23 Oct 2019

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Clinical Result

Indication

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Evaluation

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Biosimilar

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