Delving into the Latest Updates on Kanitinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

Mechanism

VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication

Esophageal CarcinomaMetastatic Solid TumorProstatic Cancer

Originator Organization

Guangzhou Esa Biotech Co., Ltd.

Active Organization

Beijing Konruns Pharmaceutical Co., Ltd.

Inactive Organization

Guangzhou Esa Biotech Co., Ltd.

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (CN)

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Structure/Sequence

Molecular FormulaC38H43F2N4O8P

InChIKeyCBEPUWADSVKALO-UHFFFAOYSA-N

CAS Registry1312225-31-2

主要目的：评价CX1003单次和连续多次给药在复发晚期或转移性实体瘤患者中的安全性和耐受性，确定最大耐受剂量（MTD）和II期试验推荐剂量。次要目的：评价CX1003单次和连续多次给药的药代动力学特征；评价CX1003治疗复发晚期或转移性实体瘤患者的客观缓解率（ORR），缓解期（DOR），疾病控制率（DCR）和无进展生存期（PFS）。

[Translation]

Primary objective: To evaluate the safety and tolerability of single and continuous multiple administrations of CX1003 in patients with relapsed advanced or metastatic solid tumors, and to determine the maximum tolerated dose (MTD) and recommended dose for Phase II trials. Secondary objectives: To evaluate the pharmacokinetic characteristics of single and continuous multiple administrations of CX1003; to evaluate the objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and progression-free survival (PFS) of CX1003 in patients with relapsed advanced or metastatic solid tumors.

Start Date11 May 2020

Sponsor / Collaborator

Beijing Konruns Pharmaceutical Co., Ltd.

NCT04093466

/ RecruitingPhase 1

A Phase 1, Multicenter, Open-label, Dose Escalation/expansion Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of CX1003 (Kanitinib) in the Patients with Relapsed Advanced or Metastatic Solid Tumors

CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR/MET). This study aimed to evaluate the safety, pharmacokinetics, and antitumor activity of CX1003 in patients with refractory advanced or metastatic solid tumors.

Start Date27 Apr 2020

Sponsor / Collaborator

Beijing Konruns Pharmaceutical Co., Ltd.

[+3]

CTR20160734

/ CompletedPhase 1

评价康尼替尼治疗复发或转移性恶性实体肿瘤的安全性、耐受性和药代动力学的开放、剂量递增的I期临床研究

[Translation] An open-label, dose-escalating phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of conititinib in the treatment of recurrent or metastatic malignant solid tumors

评价复发或转移性实体肿瘤患者对康尼替尼单次给药和连续多次给药的安全性和耐受性，并确定康尼替尼的最大耐受剂量（MTD）或II期试验推荐剂量。

[Translation]

To evaluate the safety and tolerability of single and multiple doses of conitiinib in patients with recurrent or metastatic solid tumors, and to determine the maximum tolerated dose (MTD) of conitiinib or the recommended dose for Phase II trials.

Start Date01 Mar 2017

Sponsor / Collaborator

Beijing Konruns Pharmaceutical Co., Ltd.

100 Clinical Results associated with Kanitinib

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100 Translational Medicine associated with Kanitinib

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100 Patents (Medical) associated with Kanitinib

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1

Literatures (Medical) associated with Kanitinib

01 Aug 2019·Bioanalysis

CX1003 Quantification by Ultra-Performance LC–MS/MS in Human Plasma and its Application to a Pharmacokinetic Study in Solid Tumor Patients

Article

Author: Jiang, Ji ; Li, Yu ; Hu, Pei ; Zhao, Qian

Aim: CX1003 is a novel multitargeted receptor tyrosine kinase inhibitor targeting cancer patients with relapsed or metastatic malignant solid tumors. The study aimed to develop a robust and rapid assay approach to quantify CX1003 in human plasma. Methodology & results: Samples of plasma were purified by SPE where the diluted eluates were then separated by a Waters Acquity CSH C18 column and thereafter detected using positive electrospray ionization via an ultra performance LC–MS/MS. Conclusion: The method to quantify CX1003 in human plasma was first exploited and validated with good sensitivity and specificity, and successfully fulfilled the requirement of the first-in-human clinical pharmacokinetic study of CX1003 in Chinese patients with relapsed or metastatic malignant solid tumors.

100 Deals associated with Kanitinib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malignant Solid Neoplasm	Phase 1	CN	Beijing Konruns Pharmaceutical Co., Ltd.	01 Mar 2017
Advanced Malignant Solid Neoplasm	Phase 1	CN	Beijing Konruns Pharmaceutical Co., Ltd.	01 Nov 2016
Metastatic Solid Tumor	Phase 1	CN	Beijing Konruns Pharmaceutical Co., Ltd.	01 Nov 2016
Esophageal Carcinoma	Phase 1	CN	Beijing Konruns Pharmaceutical Co., Ltd.	01 Apr 2016
Esophageal Carcinoma	Phase 1	CN	Guangzhou Esa Biotech Co., Ltd.	01 Apr 2016
Prostatic Cancer	Phase 1	CN	Guangzhou Esa Biotech Co., Ltd.	01 Apr 2016
Prostatic Cancer	Phase 1	CN	Beijing Konruns Pharmaceutical Co., Ltd.	01 Apr 2016