Delving into the Latest Updates on XS-03 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Target-

Mechanism-

Therapeutic Areas

Neoplasms

Active Indication

Solid tumor

Inactive Indication-

Originator Organization

Jiangsu Xingsheng Xinhui Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Xingsheng Xinhui Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：剂量爬坡阶段：评价XS-03片在RAS突变晚期实体瘤患者中的安全性和耐受性。确定XS-03片的最大耐受剂量(MTD)和/或II期临床研究推荐剂量(RP2D)。剂量扩展阶段：评价XS-03片在RAS突变晚期实体瘤患者中的初步疗效。次要目的：剂量爬坡阶段：确定XS-03片单次、多次口服给药后的药代动力学特征(PK)。初步评估XS-03片在RAS突变晚期实体瘤患者中的疗效。剂量扩展阶段：评价XS-03片在RAS突变晚期实体瘤患者中的安全性；确定XS-03片单次、多次口服给药后的药代动力学特征。

[Translation]

Primary objective: Dose escalation phase: Evaluate the safety and tolerability of XS-03 tablets in patients with RAS-mutated advanced solid tumors. Determine the maximum tolerated dose (MTD) and/or recommended dose (RP2D) of XS-03 tablets for Phase II clinical studies. Dose expansion phase: Evaluate the preliminary efficacy of XS-03 tablets in patients with RAS-mutated advanced solid tumors. Secondary objective: Dose escalation phase: Determine the pharmacokinetic characteristics (PK) of XS-03 tablets after single and multiple oral administration. Preliminary evaluation of the efficacy of XS-03 tablets in patients with RAS-mutated advanced solid tumors. Dose expansion phase: Evaluate the safety of XS-03 tablets in patients with RAS-mutated advanced solid tumors; Determine the pharmacokinetic characteristics of XS-03 tablets after single and multiple oral administration.

Start Date30 Nov 2023

Sponsor / Collaborator

Jiangsu Xingsheng Xinhui Pharmaceutical Co., Ltd.

100 Clinical Results associated with XS-03

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100 Translational Medicine associated with XS-03

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100 Patents (Medical) associated with XS-03

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100 Deals associated with XS-03

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