Delving into the Latest Updates on ZL-2302 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

ALK

Mechanism

ALK inhibitors(Anaplastic lymphoma kinase inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

ALK positive Non-Small Cell Lung CancerNon-Small Cell Lung Cancer

Inactive Indication-

Originator Organization

Sanofi

Active Organization

Sanofi

Zai Lab (Shanghai) Co., Ltd.

Inactive Organization

Jiangsu Xuantai Pharmaceutical Co., Ltd

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (CN)

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主要目的：评估ZL-2302在ALK阳性晚期NSCLC患者中的剂量限制性毒性（DLT）和最大耐受剂量（MTD）、单次和连续给药的安全性和耐受性、药代动力学特征及确定ZL-2302在后期研究中的推荐剂量。次要目的：初步评价ZL-2302推荐剂量对经标准治疗无效的ALK阳性的晚期NSCLC的抗肿瘤活性、用于一线治疗ALK阳性晚期NSCLC的抗肿瘤活性、安全性和耐受性及用于一线治疗CNS转移ALK阳性晚期NSCLC的抗肿瘤活性

[Translation]

Primary objective: To evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), safety and tolerability of single and continuous administration, pharmacokinetic characteristics of ZL-2302 in patients with ALK-positive advanced NSCLC, and to determine the recommended dose of ZL-2302 in later studies. Secondary objectives: To preliminarily evaluate the anti-tumor activity of the recommended dose of ZL-2302 in patients with ALK-positive advanced NSCLC who have failed standard treatment, the anti-tumor activity, safety and tolerability of first-line treatment of ALK-positive advanced NSCLC, and the anti-tumor activity of first-line treatment of CNS metastatic ALK-positive advanced NSCLC.

Start Date-

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

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100 Clinical Results associated with ZL-2302

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100 Translational Medicine associated with ZL-2302

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100 Patents (Medical) associated with ZL-2302

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100 Deals associated with ZL-2302

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	Phase 1	CN	Zai Lab (Shanghai) Co., Ltd.	05 Sep 2018
Non-Small Cell Lung Cancer	Phase 1	-	Sanofi	-
Lung Cancer	Discovery	CN	Jiangsu Xuantai Pharmaceutical Co., Ltd	05 Sep 2018