Delving into the Latest Updates on CGT-9475 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CGT 9475, CGT-9475, CGT9475

Target

ALK

Action

inhibitors

Mechanism

ALK inhibitors(Anaplastic lymphoma kinase inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

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

Inactive Indication-

Originator Organization

CGeneTech (Suzhou, China) Co. Ltd.

Active Organization

CGeneTech (Suzhou, China) Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要研究目的：评价CGT 9475在间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性肺癌患者中的安全性，确定最大耐受剂量（MTD），并评价CGT-9475单次口服治疗的剂量限制性毒性（DLT），初步确定推荐的II期临床试验剂量（RP2D）。次要研究目的：评价CGT-9475在间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性肺癌患者的人体药代动力学（PK）特征。探索性研究目的：初步评价CGT-9475的抗肿瘤疗效（ORR、PFS、DOR、DCR和CBR）。

[Translation]

Main study objectives: To evaluate the safety of CGT-9475 in patients with locally advanced or metastatic lung cancer who are positive for anaplastic lymphoma kinase (ALK), determine the maximum tolerated dose (MTD), and evaluate the dose-limiting toxicity (DLT) of a single oral treatment of CGT-9475, and preliminarily determine the recommended Phase II clinical trial dose (RP2D). Secondary study objectives: To evaluate the human pharmacokinetic (PK) characteristics of CGT-9475 in patients with locally advanced or metastatic lung cancer who are positive for anaplastic lymphoma kinase (ALK). Exploratory study objectives: To preliminarily evaluate the anti-tumor efficacy (ORR, PFS, DOR, DCR and CBR) of CGT-9475.

Start Date-

Sponsor / Collaborator

CGeneTech (Suzhou, China) Co. Ltd.

100 Clinical Results associated with CGT-9475

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100 Translational Medicine associated with CGT-9475

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100 Patents (Medical) associated with CGT-9475

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100 Deals associated with CGT-9475

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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 Lung Cancer	Phase 2	China	CGeneTech (Suzhou, China) Co. Ltd.	20 Mar 2025
Non-Small Cell Lung Cancer	Phase 1	United States	CGeneTech (Suzhou, China) Co. Ltd.	22 Jul 2022
ALK positive Non-Small Cell Lung Cancer	IND Approval	China	CGeneTech (Suzhou, China) Co. Ltd.	13 Jun 2022