Delving into the Latest Updates on RX608 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Advanced Malignant Solid Neoplasm

Inactive Indication-

Originator Organization

Suzhou NeuPharma Co., Ltd.

Active Organization

Suzhou NeuPharma Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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剂量递增部分（Ia期）：主要目的: 考察RX608多次给药在人体内的安全性、耐受性，并确定最大耐受剂量（MTD）或最佳生物学剂量（OBD）；次要目的：初步评价RX608多次给药的药代动力学特征；初步评估RX608应用于晚期恶性实体肿瘤患者的抗肿瘤疗效。剂量扩展部分（Ib期）：主要目的: 进一步评估RX608应用于MAPK信号通路驱动基因突变患者中的抗肿瘤疗效；次要目的：进一步考察RX608多次给药在人体内的安全性、耐受性，并确定II期研究的推荐给药剂量（RP2D）。

[Translation]

Dose escalation part (Phase Ia): Main purpose: To investigate the safety and tolerability of multiple administrations of RX608 in humans, and determine the maximum tolerated dose (MTD) or optimal biological dose (OBD); Secondary purpose: To preliminarily evaluate the pharmacokinetic characteristics of multiple administrations of RX608; To preliminarily evaluate the anti-tumor efficacy of RX608 in patients with advanced malignant solid tumors. Dose expansion part (Phase Ib): Main purpose: To further evaluate the anti-tumor efficacy of RX608 in patients with MAPK signaling pathway driven gene mutations; Secondary purpose: To further investigate the safety and tolerability of multiple administrations of RX608 in humans, and determine the recommended dose (RP2D) for Phase II studies.

Start Date-

Sponsor / Collaborator

Suzhou NeuPharma Co., Ltd.

100 Clinical Results associated with RX608

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100 Translational Medicine associated with RX608

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100 Patents (Medical) associated with RX608

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100 Deals associated with RX608

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