Delving into the Latest Updates on PLB-1003 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

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 3	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	(ishpzwlakf) = A lipase elevation of DLT event was observed at 250 mg BID wvhyemuqri (eilohcdbma ) View more	Positive	07 Sep 2019