EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), HER4 antagonists(Receptor protein-tyrosine kinase erbB-4 antagonists)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

EGFR positive non-small cell lung cancerNon-Small Cell Lung CancerSquamous Cell Carcinoma of Head and Neck

Inactive Indication

Advanced Lung Non-Small Cell Carcinoma

Originator Organization

Fochon Pharmaceuticals Ltd.

Active Organization

Fochon Pharmaceuticals Ltd.

Inactive Organization

Jinzhou Ahon Pharmaceutical Co., Ltd.

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Clinical Trials associated with FCN-411

NCT03420079 / Unknown statusPhase 1/2

A Phase I, Multi-center, Open-label, Single-arm, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activities of FCN-411 Monotherapy in Advanced Non-small Cell Lung Cancer

This phase I trial with dose-escalation stage and dose-expansion stage is the first-in-human study of FCN-411, a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of FCN-411 monotherapy in EGFR-positive mutation non-small cell lung cancer chinese patients. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the anti-tumor activities of FCN-411.

Start Date01 Aug 2018

Sponsor / Collaborator

Jinzhou Ahon Pharmaceutical Co., Ltd.

[+1]

CTR20160812 / RecruitingPhase 1

评价FCN-411在EGFR突变阳性的晚期非小细胞肺癌患者中的安全性、耐受性、疗效和药代动力学

[Translation] To evaluate the safety, tolerability, efficacy and pharmacokinetics of FCN-411 in patients with EGFR mutation-positive advanced non-small cell lung cancer

主要目的： 1、观察单次口服和连续口服FCN-411单药在经过一代EGFR-TKI治疗失败，EGFR外显子19/21突变的晚期NSCLC患者中的安全性和耐受性；2、确定EGFR突变的晚期NSCLC患者口服FCN-411的MTD和RP2D。次要目的： 1、初步观察FCN-411单药对EGFR基因突变的晚期NSCLC患者的疗效； 2、确定单次和连续服用FCN-411的药物代谢动力学特征。

[Translation]

Primary objectives: 1. To observe the safety and tolerability of single and continuous oral administration of FCN-411 monotherapy in patients with advanced NSCLC with EGFR exon 19/21 mutations who have failed first-generation EGFR-TKI treatment; 2. To determine the MTD and RP2D of oral FCN-411 in patients with advanced NSCLC with EGFR mutations. Secondary objectives: 1. To preliminarily observe the efficacy of FCN-411 monotherapy in patients with advanced NSCLC with EGFR gene mutations; 2. To determine the pharmacokinetic characteristics of single and continuous administration of FCN-411.

Start Date01 Aug 2018

Sponsor / Collaborator

Fochon Pharmaceuticals Ltd.

100 Clinical Results associated with FCN-411

100 Translational Medicine associated with FCN-411

100 Patents (Medical) associated with FCN-411

Literatures (Medical) associated with FCN-411

01 Mar 2020·BioanalysisQ4 · MEDICINE

A Validated Ultra-Performance LC–MS/MS Method for Quantifying a Novel Oral EGFR Inhibitor FCN-411 in Human Plasma

Q4 · MEDICINE

Article

Author: Song, Yuanyuan ; Han, Xiaohong ; Shi, Yuankai ; Liu, Shuxia ; Wu, Di ; Lin, Lin

Aim: To investigate the clinical pharmacokinetic profiles of FCN-411, a new EGFR tyrosine kinase inhibitor, an ultra-performance LC–MS/MS method was developed. Methods & results: The method was suitable to determine FCN-411 in plasma due to the fast sample preparation (protein precipitation procedure), a good linear range of 2–500 ng/ml, low amount of sample volume (5 μl) and less run time (4.5 min) for analysis. And it was demonstrated to be acceptable according to the guidelines for bioanalytical assay validation. Conclusion: The method was robust, sensitive and repeatable, and it is ready to be applied to measure FCN-411 in a Phase I clinical pharmacokinetic study.

100 Deals associated with FCN-411

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Jinzhou Ahon Pharmaceutical Co., Ltd.	01 Aug 2018
EGFR positive non-small cell lung cancer	Phase 1	CN	Fochon Pharmaceuticals Ltd.	01 Aug 2018
Non-Small Cell Lung Cancer	Phase 1	-	Fochon Pharmaceuticals Ltd.	-
Squamous Cell Carcinoma of Head and Neck	Phase 1	-	Fochon Pharmaceuticals Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03420079 (Pubmed) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Exon 18 Mutation \| EGFR Exon 19 Mutation \| EGFR Exon 20 Mutation ... View more	77	FCN 411	ykodngqgdw(erpkwjnmyt) = diarrhea (8; 10.4%) and dermatitis acneiform (7; 9.1%) mmnaobfezb (gamyuwkrdk )	Positive	03 Feb 2022

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