Delving into the Latest Updates on PLB-1003 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

PLB 1003, PLB1003

Target

ALK

Mechanism

ALK inhibitors(Anaplastic lymphoma kinase inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

ALK positive Non-Small Cell Lung Cancer

Inactive Indication

ALK positive Lung Cancer

Originator Organization

Beijing Purunao Biotechnology Co Ltd

Active Organization

Beijing Purunao Biotechnology Co Ltd

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

RegulationSpecial Review Project (CN)

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主要目的：主要目的是在ALK阳性的晚期非小细胞肺癌(NSCLC)患者中考察PLB1003胶囊单次和多次口服给药的耐受性及安全性, 确定剂量限制性毒性（DLT）、最大耐受剂量（MTD）/推荐剂量（RD）。次要目的：考察PLB1003胶囊在ALK阳性的晚期NSCLC患者中口服的单次和多次药代动力学特征。初步评价PLB1003胶囊对ALK阳性的晚期NSCLC的抗肿瘤活性。

[Translation]

Primary objective: The primary objective is to investigate the tolerability and safety of single and multiple oral administration of PLB1003 capsules in patients with ALK-positive advanced non-small cell lung cancer (NSCLC), and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD)/recommended dose (RD). Secondary objective: To investigate the pharmacokinetic characteristics of single and multiple oral administration of PLB1003 capsules in patients with ALK-positive advanced NSCLC. To preliminarily evaluate the antitumor activity of PLB1003 capsules against ALK-positive advanced NSCLC.

Start Date24 Feb 2017

Sponsor / Collaborator

Beijing Purunao Biotechnology Co Ltd

NCT03130881 / Unknown statusPhase 1

A Phase I Open-label, Multicenter Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of PLB1003 in Patients With ALK-positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC)

This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1003.

Start Date08 Nov 2016

Sponsor / Collaborator

Beijing Purunao Biotechnology Co Ltd

100 Clinical Results associated with PLB-1003

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100 Translational Medicine associated with PLB-1003

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100 Patents (Medical) associated with PLB-1003

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100 Deals associated with PLB-1003

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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 1	CN	Beijing Purunao Biotechnology Co Ltd	08 Nov 2016
ALK positive Non-Small Cell Lung Cancer	Phase 1	CN	Beijing Purunao Biotechnology Co Ltd	08 Nov 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03130881 (WCLC2019) Manual	Phase 1	Non-Small Cell Lung Cancer ALK rearrangements	21	PLB1003	mgihvunypf(lxmgykkhqy) = A lipase elevation of DLT event was observed at 250 mg BID oryxbefgki (itmcwuyuyh ) View more	Positive	07 Sep 2019