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Clinical Trial Summary

This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP.


Clinical Trial Description

This study is a Phase 1b, open-label, multicenter, single-arm study to evaluate the safety, tolerability, and preliminary efficacy of HMPL-523 in adult subjects with primary ITP diagnosed at least 3 months prior to enrollment or randomization. In the dose escalation stage (Part 1), subjects will receive one of 3 dose levels of HMPL-523 to determine the recommended dose of HMPL-523 for the randomized dose optimization- stage (Part 2). At the end of Part 1, 2 dose levels will be selected to be used in the dose-optimization stage (Part 2) of the study. In Part 2 of the study, subjects will be randomized in a 1:1 ratio between the 2 dose levels to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the Recommended Phase 3 dose (RP3D) of HMPL-523 will be determined based on the safety, efficacy and PK data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06291415
Study type Interventional
Source Hutchmed
Contact Nick Lawn
Phone +1-973-306-4490
Email 2022-523-GLOB1@hutch-med.com
Status Recruiting
Phase Phase 1
Start date April 2, 2024
Completion date November 2026

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