Delving into the Latest Updates on RG-001 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target

SHP2

Mechanism

SHP2 inhibitors(Src homology phosphotyrosyl phosphatase 2 inhibitors)

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Shanghai Lingji Biotechnology Co., Ltd.

Active Organization

Shanghai Lingji Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价RG001片在标准治疗失败的晚期实体瘤患者的安全性和耐受性，并探索RG001片的最大耐受剂量（MTD），确定Ⅱ期临床试验推荐剂量（RP2D）。次要目的： 1）评价RG001片的药代动力学（PK）和药效学（PD）特征； 2）初步评价RG001片在晚期实体瘤患者中的疗效。

[Translation]

Primary objective: To evaluate the safety and tolerability of RG001 tablets in patients with advanced solid tumors who have failed standard treatment, and to explore the maximum tolerated dose (MTD) of RG001 tablets and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of RG001 tablets; 2) To preliminarily evaluate the efficacy of RG001 tablets in patients with advanced solid tumors.

Start Date23 Sep 2021

Sponsor / Collaborator

Shanghai Lingji Biotechnology Co., Ltd.

100 Clinical Results associated with RG-001

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100 Translational Medicine associated with RG-001

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100 Patents (Medical) associated with RG-001

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100 Deals associated with RG-001

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