Delving into the Latest Updates on Ficonalkib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CT-3505, SY-3505

Target

ALK

Mechanism

ALK inhibitors(Anaplastic lymphoma kinase inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

ALK positive Non-Small Cell Lung CancerAdvanced Lung Non-Small Cell CarcinomaLTK-positive Solid Tumors

Inactive Indication-

Originator Organization

Shouyao Holdings (Beijing) Co. Ltd.

Active Organization

Shouyao Holdings (Beijing) Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Primary objective: To evaluate the efficacy of CT-3505 capsules compared with crizotinib capsules in patients with ALK-positive NSCLC who are undergoing treatment for the first time. Secondary objective: To evaluate the safety of CT-3505 capsules in patients with ALK-positive NSCLC who are undergoing treatment for the first time.

Start Date22 Mar 2024

Sponsor / Collaborator

Shouyao Holdings (Beijing) Co. Ltd.

100 Clinical Results associated with Ficonalkib

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100 Translational Medicine associated with Ficonalkib

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100 Patents (Medical) associated with Ficonalkib

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100 Deals associated with Ficonalkib

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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 3	CN	Shouyao Holdings (Beijing) Co. Ltd.	22 Mar 2024
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Shouyao Holdings (Beijing) Co. Ltd.	30 Jun 2023
LTK-positive Solid Tumors	Phase 1	CN	Shouyao Holdings (Beijing) Co. Ltd.	30 Aug 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05257512 \| ChiCTR1900025619 (Pubmed) Manual	Phase 1/2	ALK positive Non-Small Cell Lung Cancer ALK Positive	127	Ficonalkib 25-800 mg QD (dose-escalation phase)	cqyrjctkck(yuhtdohwrn) = ddjozasjlf ecwsteukhf (nzkwqijado, 26.1-51.8) View more	Positive	29 Jan 2024
				Ficonalkib 500 mg QD or 600 mg QD (dose-expansion phase)	-
NCT05257512 (ASCO2023) Manual	Phase 1/2	ALK positive Non-Small Cell Lung Cancer ALK Expression	82	CT-3505	krdiutaepx(ttobntdowb) = nanaiuwcls sznzvisguo (duijmkyinp, 24.0 - 45.5) View more	Positive	31 May 2023
				CT-3505 (patients received SY-3505 at 600mg once daily)	krdiutaepx(ttobntdowb) = qjqjzwipin sznzvisguo (duijmkyinp, 24.5 - 53.6) View more