Delving into the Latest Updates on XNW-21015 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

XNW 21015, XNW21015

Target

HPK1

Action

inhibitors

Mechanism

HPK1 inhibitors(Mitogen-activated protein kinase kinase kinase kinase 1 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [2]

Active Indication

Advanced Malignant Solid NeoplasmColorectal CancerMelanoma+ [5]

Inactive Indication-

Originator Organization

Evopoint Biosciences Co., Ltd.

Active Organization

Evopoint Biosciences Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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剂量递增阶段研究目的主要目的：评估XNW21015在晚期实体瘤受试者中的安全性和耐受性；确定XNW21015的最大耐受剂量（MTD）、II期推荐剂量（RP2D）。次要目的：评估XNW21015及主要代谢产物的药代动力学（PK）特征；评估XNW21015的药效动力学（PD）特征；初步评估XNW21015治疗晚期实体瘤的抗肿瘤疗效。剂量扩展阶段研究目的主要目的：评估XNW21015在晚期实体瘤受试者中的抗肿瘤疗效。次要目的：评估XNW21015的安全性和耐受性；评估XNW21015及主要代谢产物的药代动力学（PK）特征；评估XNW21015的药效动力学（PD）特征。

[Translation]

Purpose of the dose escalation phase study Main purpose: To evaluate the safety and tolerability of XNW21015 in subjects with advanced solid tumors; To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of XNW21015. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of XNW21015 and its main metabolites; To evaluate the pharmacodynamic (PD) characteristics of XNW21015; To preliminarily evaluate the anti-tumor efficacy of XNW21015 in the treatment of advanced solid tumors. Purpose of the dose expansion phase study Main purpose: To evaluate the anti-tumor efficacy of XNW21015 in subjects with advanced solid tumors. Secondary purpose: To evaluate the safety and tolerability of XNW21015; To evaluate the pharmacokinetic (PK) characteristics of XNW21015 and its main metabolites; To evaluate the pharmacodynamic (PD) characteristics of XNW21015.

Start Date14 Oct 2023

Sponsor / Collaborator

Evopoint Biosciences Co., Ltd.

100 Clinical Results associated with XNW-21015

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100 Translational Medicine associated with XNW-21015

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100 Patents (Medical) associated with XNW-21015

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100 Deals associated with XNW-21015

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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	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Colorectal Cancer	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Melanoma	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Non-Small Cell Lung Cancer	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Renal Cell Carcinoma	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Squamous Cell Carcinoma of Head and Neck	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Triple Negative Breast Cancer	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023
Uterine Cervical Cancer	Phase 1	China	Evopoint Biosciences Co., Ltd.	14 Oct 2023