Delving into the Latest Updates on Pirotinib Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Pirotinib, KBP 5209, KBP-5209

Target

EGFR x HER2 x HER4

Action

antagonists

Mechanism

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

Therapeutic Areas

NeoplasmsRespiratory DiseasesSkin and Musculoskeletal Diseases

Active Indication-

Inactive Indication

Advanced Malignant Solid NeoplasmBreast CancerNon-Small Cell Lung Cancer+ [1]

Originator Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Active Organization-

Inactive Organization

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

Sihuan Pharmaceutical Holdings Group Ltd.

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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This phase II, umbrella trial study directed by next generation sequencing (NGS) works in Chinese patients with advanced stage NSCLC who never received any anti-tumor treatment. The purpose of this study is to evaluate efficacy of targeted therapies or immunotherapy to NSCLC patients whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.

Start Date09 Jul 2018

Sponsor / Collaborator

Chinese Thoracic Oncology Group

CTR20150792

/ CompletedPhase 1

KBP-5209治疗晚期实体肿瘤的I期临床研究

[Translation] Phase I clinical study of KBP-5209 in the treatment of advanced solid tumors

主要目的： 1. 确定KBP-5209的MTD和RP2D，并评价KBP- 5209单药口服在晚期实体瘤患者中的DLT； 2. 确定 KBP-5209在经标准治疗复发或缺乏标准治疗的晚期实体瘤患者的安全性和耐受性，包括急性和慢性毒性；次要目的： 1. 确定KBP-5209在单次和多次给药条件下的PK特征及其代谢； 2. 初步考察患者的ORR，包括PR和CR； 3. 初步评估KBP-5209的药效动力学； 4. 确定目标适应症人群。

[Translation]

Primary objectives: 1. To determine the MTD and RP2D of KBP-5209, and to evaluate the DLT of oral monotherapy of KBP-5209 in patients with advanced solid tumors; 2. To determine the safety and tolerability of KBP-5209 in patients with advanced solid tumors who have relapsed after standard treatment or lack standard treatment, including acute and chronic toxicity; Secondary objectives: 1. To determine the PK characteristics and metabolism of KBP-5209 under single and multiple dosing conditions; 2. To preliminarily investigate the ORR of patients, including PR and CR; 3. To preliminarily evaluate the pharmacodynamics of KBP-5209; 4. To determine the target indication population.

Start Date05 Nov 2015

Sponsor / Collaborator

Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.

NCT02442414

/ CompletedPhase 1

A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

Start Date07 Apr 2015

Sponsor / Collaborator

Beijing Sihuan Pharmaceutical Co. Ltd.

[+2]

100 Clinical Results associated with Pirotinib Hydrochloride

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100 Translational Medicine associated with Pirotinib Hydrochloride

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100 Patents (Medical) associated with Pirotinib Hydrochloride

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100 Deals associated with Pirotinib Hydrochloride

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	China	Sihuan Pharmaceutical Holdings Group Ltd.	31 Jul 2018
Breast Cancer	Phase 2	China	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	01 Aug 2015
Non-Small Cell Lung Cancer	Phase 2	China	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	01 Aug 2015
Advanced Malignant Solid Neoplasm	Phase 1	China	Shandong Xuanzhu Pharmaceutical Technology Co., Ltd.	05 Nov 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02442414 (ASCO 12017 \| ASCO 22017) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	23	KBP-5209 (15 females, 8 males；Tumor types：breast (6), CRC (4), ovarian (3), H&N (2), sarcoma (2), and NSCLC, sinus, gastric, gallbladder, pancreas, CUP tumor (1 each)；median age 57 (37-79)；)	mvlkhxsbta(mefhaxnvjy) = 4 pts. diarrhea (1 pt, 70mg QD; 1pt, 80mg QD), nausea and vomiting (1pt, 70mg QD), and diarrhea, nausea and vomiting (1 pt, 80mg QD) qlrrmaauoe (grvuknjlip ) View more	Positive	05 Jun 2017